BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211103 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06120
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE NEUROSTIMULATOR PRODUCED HIGH IMPEDANCES WHEN CONNECTED TO THE LEAD. WHEN THE LEAD WAS CONNECTED TO THE TRIAL CABLE IT MEASURED NORMAL IMPEDANCES. AFTER TROUBLESHOOTING, THE NEUROSTIMULATOR WAS NOT USED AND A NEW DEVICE IMPLANTED IN ITS PLACE. NO INJURIES WERE REPORTED AND THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB089822V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB096788V| IMPLANTED:| STIM ACCESSORY: MODEL 3555-31, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V700357046