BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2043185 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02310
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING IMPLANT OF A TRIAL NO STIMULATION WAS ACHIEVED ALTHOUGH A MAX OF 10 V HAD BEEN REACHED. ALL IMPEDANCES WERE OUT OF RANGE. ANOTHER ENS WAS USED, IMPEDANCES WERE AGAIN MEASURED, AND (B)(4). THE LEADS WERE REMOVED FROM THE SNAP LID, CLEANED AND THEN RETESTED. AGAIN ALL BUT (B)(4); HOWEVER, THEY WERE NOT ALL THE SAME AS ON THE PREVIOUS TEST. A THIRD ENS WAS THEN TESTED, AGAIN ALL READ OUT OF RANGE. THE LEADS WERE TESTED IN A JUG OF NORMAL SALINE AND ALL CONTACT READINGS CAME UP AS XXX. AGAIN THEY WERE TESTED AND THE SAME READING WAS AGAIN OBTAINED. AT THIS POINT THE PHYSICIAN ABANDONED THE PROCEDURE AND THE LEADS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3555-31, LOT# UNK| LEAD: MODEL 3877, LOT# UNK| LEAD: MODEL 3877, LOT# UNK