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Saturday, March 22, 2008

Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps Recall

Class I Recall: Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps

Date Recall
Initiated

January 21, 2008

Product:

Medtronic Neuromodulation Implantable Infusion Pumps:

  • SynchroMed EL Implantable Infusion Pump, Models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, 8627L-18
  • SynchroMed II Implantable Infusion Pump, Models 8637-20, 8637-40,
  • IsoMed Implantable Infusion Pump, Models 8472-20, 8472-35, 8472-60.
The implantable components of the infusion systems listed above include the pump, a side catheter access port, catheters, and/or catheter accessories.
Use:

These devices administer drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.

Recalling Firm:
Medtronic Neuromodulation
800 53rd Avenue NE
Minneapolis, Minnesota 55440-1250
Reason for Recall:

The company updated the labeling for the devices to include current patient management and treatment recommendations. The company also received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. For more detailed information, please see the link below to the company’s press release.

Public Contact:

Patients or customers may contact Medtronic Neuromodulation at 1-800-707-0933 from Monday - Friday, 7:00 a.m. – 6:00 p.m. (Central Standard Time) or by emailing the company at: http://www.medtronic.com/corporate/contact.jsp

FDA District:
Minneapolis
FDA Comments:

On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps.

Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.

For more information about this recall, including Medtronic's letter to physicians, please see the company’s press release at: http://wwwp.medtronic.com/Newsroom/ NewsReleaseDetails.do?itemId=1205958103681

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

  • Online:www.fda.gov/MedWatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • FAX: 1-800-FDA-0178

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