BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 1140630 · Received August 28, 2008

    Report

    Report Number
    2182207-2008-05281
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE RECHARGING SYSTEM HAD BEEN WORKING EFFECTIVELY SINCE IMPLANT. THE ELECTRIC LEAD FROM THE RECHARGING UNIT TO THE ANTENNA DETACHED FROM THE ELECTRIC CABLE AND LODGED WITHIN THE ANTENNA. THE RECHARGING SYSTEM CAN NO LONGER RECHARGE AS A RESULT. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 RECHARGER SYSTEM: MODEL 37752