BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE EXTERNAL NEUROSTIMULATOR

    MDR report key: 3140435 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01811
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37022, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ACCIDENTALLY PLUGGED THE WRONG EXTERNAL NEUROSTIMULATOR (ENS) INTO THE TRIALING CABLE AND TURNED STIMULATION ON. THE PATIENT HAD 2 ENSS FOR HER TRIAL. THE ¿WRONG¿ ENS SHE PLUGGED INTO HAD MUCH HIGHER AMPLITUDES THAN THE ONE INTENDED TO BE USED. THE STIMULATION WAS SO STRONG THAT SHE COULDN¿T TALK OR MOVE. THE PATIENT¿S HUSBAND DISCONNECTED THE ENS. THE PATIENT TRIED TO STAND AND FELL, INJURING HER LEFT FOOT. THE FOOT WAS LATER XRAY¿D AND FOUND TO HAVE A HAIRLINE FRACTURE. THE PATIENT HAS A BRACE/BOOT TO SUPPORT THIS FOOT. THE PATIENT TURNED THE STIMULATION OFF FOR THE DAY AND THEN TURNED IT BACK ON THE NEXT DAY USING THE CORRECT ENS. THE PATIENTS STATUS WAS NOTED TO BE ALIVE/WITH INJURY. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242311 RESTORE EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37022

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR