BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2030439 · Received March 9, 2011

    Report

    Report Number
    3007566237-2011-01778
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE IN AN OVERDISCHARGE STATE. THE DEVICE WAS SUCCESSFULLY BROUGHT OUT OF THE OVERDISCHARGE USING THE PHYSICIAN MODE RECHARGE. IT WAS ALSO STATED THAT WHEN RECHARGING, THE DEVICE WAS TURNING OFF WHEN THE BATTERY WAS AT A 50% CHARGE. THE COUPLING BARS DISAPPEARED AND IT SEEMED EVERYTHING SHUT DOWN. THIS HAD BEEN OCCURRING FOR APPROXIMATELY SIX MONTHS. THE PT WAS USING HIGH SETTINGS, THREE PROGRAMS RUNNING AT 8.0V, 9.0V, AND 10.0V RESPECTIVELY. THE DEVICE WAS REPROGRAMMED TO ONE PROGRAM AT 4.9V WHICH ENABLED THE PT TO CHARGE EVERY 14-17 DAYS RATHER THAN DAILY. IT WAS UNCLEAR AT THIS POINT IF THE ISSUE WAS DUE TO THE RECHARGER OR THE IMPLANTED STIMULATOR. THE STIMULATOR CONTINUED TO SHUT OFF WHEN REACHING A CERTAIN CHARGE LEVEL DESPITE MULTIPLE TROUBLESHOOTING ATTEMPTS AND THE PHYSICIAN WAS CONSIDERING REPLACING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC NEUROMODULATION 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 7495-25, LOT# NAF012307N| LEAD: MODEL 3888, LOT# J0124551V| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK003504V| PROGRAMMER: MODEL 37742, LOT# NJD024620N| LEAD: MODEL 3888, LOT# L68161| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V006400| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: