BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2180648 · Received May 5, 2011

    Report

    Report Number
    1627487-2011-00608
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2007 FOR ANKLE PAIN. IT WAS REPORTED THAT THE PT ALLOWED HER IPG TO DEPLETE AFTER NO LONGER NEEDING TO UTILIZE THE STIMULATION. SHE RECENTLY ATTEMPTED TO RECHARGE THE DEVICE FOR THE PURPOSE OF COVERING A NEW PAIN AREA, BUT WAS UNABLE TO COMMUNICATE WITH THE IPG VIA HER CHARGING SYSTEM. EFFORTS TO RECHARGE THE PT'S IPG WITH A NEW CHARGING SYSTEM ALSO PROVED UNSUCCESSFUL. FOLLOW-UP ON THIS MATTER FOUND THAT NO COMMUNICATION CAN BE ESTABLISHED BETWEEN THE PT'S IPG AND TWO PROGRAMMERS. THERE ARE NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 67154

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3244