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Battery problems with two of Medtronic's SynchroMed II implantable infusion pumps have forced the company to recall them, according to the FDA, although the recall only affects products not yet implanted.
- Class 2 Device Recall SynchroMed II implantable drug infusion pump. Consignee was given a Medtronic 'Urgent Medical Device Correction' letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933.
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The company has determined that the batteries in models 8637-20 and 8637-40 develop internal films that impair performance, causing the pumps to stop working.
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These products are indicated for delivery of morphine sulfate and ziconotide for treatment of chronic pain; intrathecal baclofen for severe spasticity; and floxuridine and methotrexate for certain cancers.
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Mar 4, 2018 - If you have lost your card, you can always call Medtronic at 1800-328-2518 to see if your device is on the recall. If your serial number happens. Medtronic is committed to providing quality customer service. However, due to the number of online inquiries we receive, we may not be able to respond within the same business day. If you need a response during the same business day, call Medtronic at 800-633-8766 (toll-free within the United States) or +1 763 514 4000 (worldwide).
When the pumps stop working, patients are at risk for recurrent symptoms or withdrawal syndromes. These can be life-threatening, the FDA indicated.
In July, Medtronic had sent notices to healthcare providers, informing them of the potential for battery failure but not recalling the devices. The FDA designated that new recall as Class I, its most urgent.
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The company does not recommend removing the devices from patients already implanted with them, if they are functioning properly. It cited the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery.
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In July, the company said it had confirmed 55 cases of device malfunction, out of some 140,000 implanted worldwide.
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However, patients should contact their physicians immediately if symptoms return or if they hear a device alarm, the FDA said. Patients should also carry patient identification cards at all times.
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The SynchroMed II pumps subject to the recall were distributed from May 2004 to July 2011. Medtronic's website includes a page where customers can input serial numbers to determine whether a specific unit should be returned.