Class I Recall of Certain Medtronic Infusion Pumps

Yael Waknine

Disclosures

September 13, 2011

September 13, 2011 — A class I recall has been issued for certain Medtronic implantable programmable infusion pumps (SynchroMed II), the US Food and Drug Administration (FDA) announced yesterday.

According to the company, the batteries in models 8637-20 and 8637-40 may form a film that impairs performance. Reduced battery performance can cause sudden loss of therapy and the return of underlying symptoms and/or withdrawal symptoms, FDA officials said.

The pumps are indicated as part of an infusion system to deliver morphine sulfate and ziconotide for the treatment of chronic pain, intrathecal baclofen for severe spasticity, and floxuridine and methotrexate for primary or metastatic cancers. Affected devices were distributed between May 2004 and July 8, 2011.

The company issued an original warning about the problem in July 2009 and then sent an urgent medical device correction letter to clinicians in July 2011, citing 55 confirmed cases of malfunction among some 139,653 devices implanted worldwide.

The company does not recommend removing currently implanted pumps because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery.

Patients are encouraged to carry their patient identification cards with them at all times and to contact their physicians immediately if symptoms return or a device alarm sounds.

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," according to the FDA.

More information on the recall is available on the FDA's Web site and can also be obtained by contacting Medtronic Patient Services at 1-800-510-6735, Monday to Friday, from 8 am to 5 pm, CDT. Patient information can also be found on the company's Web site, which contains a device identification page on which customers can input serial numbers to determine whether a particular pump is being recalled.

Adverse events related to the use of the Medtronic SynchroMed II implantable infusion pump should be reported to Medtronic Neuromodulation Technical Services at 1-800-328-0810, Monday to Friday, from 8 am to 5 pm, CDT.

Adverse events also may be communicated to MedWatch, the FDA's adverse event and reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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