BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3082799 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01462
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE COMPANY REPRESENTATIVE WAS NO LONGER WITH THE COMPANY AND FURTHER FOLLOW UP WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH INTRAOPERATIVE IMPEDANCES. DURING AN IMPLANT PROCEDURE WITH ALL NEW COMPONENTS, ALL PAIRS HAD IMPEDANCES GREATER THAN 10,000 OHMS. OF NOTE, THREE LEADS WERE USED. A FOURTH LEAD WAS ADDED AND TESTED OUTSIDE OF THE PATIENT AND IMPEDANCES WERE HIGH, AS EXPECTED, AS NOTHING WAS CONDUCTIVE. THE PHYSICIAN PUT THIS LEAD INTO TISSUE AND IMPEDANCES WERE STILL GREATER THAN 10,000 OHMS. GROUP IMPEDANCES WERE ALSO HIGH. WHEN IMPEDANCES WERE RE RUN AT 3 VOLTS AND WITH A MULTI LEAD TRIALING CABLE, IMPEDANCES ON ALL PAIRS WERE GREATER THAN 40,000 OHMS. THE PATIENT WAS UNDER ANESTHESIA, SO STIMULATION COULD NOT BE TESTED. IT WAS NOTED THAT NOTHING REMARKABLE OCCURRED WITH THE COMPONENTS. IMPEDANCES HAD STARTED TO LOWER AT THE END OF THE PROCEDURE AND THE CASE PROCEEDED. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185571 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1