BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2130510 · Received June 14, 2011

    Report

    Report Number
    3007566237-2011-04387
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 17, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TESTING OF THE LEAD (MODEL 3874, (B)(4)) REVEALED BROKEN CONDUCTOR WIRES. THE #0 CONDUCTOR WIRE WAS BROKEN AT THE PROXIMAL SIDE OF THE #0 ELECTRODE. CIRCUIT #0 WAS OPEN. CIRCUITS #1 THRU #7 HAD ACCEPTABLE CONTINUITY WITH NO SHORTS. A NON-STANDARD IMPEDANCE TEST WAS PERFORMED. THE RETURNED (B)(4) SCREENING CABLE WAS CONNECTED TO AN EXTERNAL NEUROSTIMULATOR AND THE LEAD. THE ELECTRODES OF THE LEAD WERE PLACED IN 0.9% SALINE SOLUTION. IMPEDANCES MEASURED >10000 ON THE #0 ELECTRODE. TESTING OF THE SCREENING CABLE (MODEL 3550-31, (B)(4)) REVEALED THE DISTAL END CONNECTOR CONTACT WAS BROKEN. THE DOOR CLOSURE CONTACT WAS BROKEN ON THE SCREENING CABLE. TESTING OF THE ANCHOR (MODEL ANCHOR/TLOCK, SERIAL NUMBER UNK) REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    DURING A NEUROSTIMULATION TRIAL, THE EXTERNAL NEUROSTIMULATOR (ENS) INDICATED THE LEAD WAS DISCONNECTED. IT WAS VERIFIED THAT THE LEAD WAS CORRECTLY IN PLACE. THE LEAD WAS CHANGED FROM 0-7 ELECTRODES TO 8-15 ELECTRODES AND A NEW ENS WAS USED. THE ENS WOULD SPORADICALLY TURN OFF AND ON. THE PT NOTED THAT DURING THE TRIAL STIMULATION WOULD "JUST TURN OFF." THE LEAD WAS EXPLANTED AND THE PT WAS NOT INJURED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL 3550-31, LOT# N268838| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3874, LOT# V648091| STIM ACCESSORY: MODEL ANCHOR/TLOCK, LOT# UNK