BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1150393 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05466
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT LOST HER PATIENT PROGRAMMER, WAS UNABLE TO RECHARGE HER NEUROSTIMULATOR AND LOST STIMULATION SENSATION. THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. THE MANUFACTURER'S FIELD REPRESENTATIVE ATTEMPTED TO GET A REPLACEMENT PROGRAMMER. THE PATIENT UNDERWENT REVISION SURGERY AND THE LEADS WERE REPLACED. AFTER SURGERY IT WAS REPORTED THAT SHE HAD STIMULATION WHERE SHE NEEDED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| LEAD MODEL 3778 LOT# V022016006| EXPLANTED| IMPLANTED| EXTENSION MODEL 37082 LOT# NKB005384N| IMPLANTED| EXPLANTED| LEAD MODEL 3890 LOT# V008620| EXPLANTED