一級召修 Medtronic SynchroMed II (EL)mplantable Drug Infusion Pump

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Medtronic SynchroMed II Implantable Drug Infusion Pump 衛署醫器輸字第023865號 美敦力醫療產品股份有限公司　

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Feed Through Failure

Recall Class: Class I
Date Recall Initiated: June 3, 2013
Products: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps

• SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
• SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size)

This recall does not affect Medtronic external insulin pumps for diabetes.
These recalled products were manufactured from May 1998 through June, 2013 and distributed from April 1999 through June 2013.
Use: The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.
The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.

Recalling Firm:Medtronic, Inc. Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568

Manufacturer:Medtronic Puerto Rico Operations Co.
50 Road 31 km 24.4 Ceiba Norte Ind Park
Juncos, Puerto Rico 00777

Reason for Recall: There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy. This may result in the return of underlying symptoms and/or withdrawal symptoms. Use of this recalled product may result in serious adverse health consequences, including death.

Public Contact: For questions about this recall, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.

FDA District: Minneapolis District Office
FDA Comments:
Patients: Maintain regular follow-up appointments with your physicians. However, if you experience a change or return of symptoms or hear a device alarm, contact your physician immediately.
Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Correction letter.

On June 3, 2013, Medtronic sent an "Urgent: Medical Device Correction¹"² letter dated May 2013 to all affected customers. The letter described the issue of a pump’s potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations.

The firm is asking health care providers to return any explanted SynchroMed II implantable infusion pump to Medtronic Returned Products Analysis.
These actions are not expected to cause a device shortage.
Customers can contact their Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program³ either online, by regular mail or by FAX.

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Additional Links:

• Firm Press Release⁴⁵

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Recall Class: Class I

Date Recall Initiated: November 9, 2012

Products: Medtronic SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump
Model numbers:

• SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.)
• SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18

These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012.

Use:
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Infusion Pumps) contain and administer prescribed drugs or fluids to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. More information related to the drugs approved for use with the SynchroMed Infusion Pump can be found by reviewing the Medtronic Summary of Approved Drugs, which can be found by accessing the link under the Additional Information section below.

Recalling Firm: Medtronic Neuromodulation 7000 Central Ave NE Minneapolis, Minnesota 55432-3568

Reason for Recall: Medtronic recently notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump’s performance. Based on data from the firm’s Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. A cessation of drug infusion may cause serious adverse health consequences, including death. The firm reminded healthcare professionals that the SynchroMed pump can experience motor stalls when used with either approved or unapproved drugs, however pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used.

The firm's Medical Device Safety Notification1 includes detailed information about this issue. In addition to the Healthcare Professional Letter, the following important enclosures were provided:

• A white paper documenting the Increased Risk of Motor Stall and Loss of or Change in Therapy when Unapproved Drug Formulations are used with the SynchroMed Pump: and
• A summary of the drugs that are approved to be used with the SynchroMed.

Medtronic also reiterated that it continues to investigate motor gear corrosion, which has been identified as a primary contributor to permanent motor stall in the SynchroMed Infusion Pump.

Public Contact: For any questions, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm Central Standard Time.

FDA District: Minneapolis District Office

FDA Comments:
Medtronic sent an Urgent Medical Device Safety Notification dated November 2012 to healthcare professionals beginning on November 9, 2012. The letter described the issue and recommendations; and physicians were asked to return a response form.

Medtronic recommendations:
To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump.
DO NOT USE compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump.

• Continue to monitor patients closely for the possible return of baseline symptoms. A return of baseline symptoms could potentially indicate pump damage.
• Reinforce with patients and caregivers information on the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare professionals immediately if these signs and symptoms appear.
• The SynchroMed II pump is designed with a critical alarm for pump motor stall. For patients implanted with a SynchroMed II pump, you can change the critical alarm interval frequency to sound every 10 minutes.
  • Remind patients, their caregivers, and your appropriate staff members to be alert for pump alarms.
  • At implant or follow-up visits, perform an alarm test to provide an opportunity for patients and caregivers to hear and differentiate between the critical and non-critical pump alarms.
  • For patients with a Personal Therapy Manager (PTM), the PTM will show alarm code 8476 when a bolus is attempted if there is an active alarm.
• Retrieve logs when interrogating the SynchroMed II pump in order to check for motor stall events. Note that a temporary motor stall with recovery is expected behavior when the pump is exposed to a strong magnetic field such as during an MRI. Medtronic Technical Services can be contacted for further assistance evaluating motor stall events on logs.
• Report any malfunction or adverse event related to a device to Medtronic Neuromodulation Technical Services and to FDA's MedWatch Program (see link below)

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program2 either online, by regular mail or by FAX.

Additional Information:

• Medtronic Medical Device Safety Notification – November 20123 - Use of Unapproved Drugs with the SynchroMed Implantable Infusion Pump