BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2120166 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-04017
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT LOST STIMULATION 6 MONTHS AFTER IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT. IMPEDANCES WERE MEASURED AND ELECTRODE 1 WAS OUT OF RANGE. THE PT WAS SUCCESSFULLY REPROGRAMMED WITHOUT USING ELECTRODE 1. FIVE MONTHS LATER, THE PT LOST STIMULATION AGAIN AND ELECTRODES 0 AND 1 WERE BOTH OUT OF RANGE. THE PT WAS SUCCESSFULLY REPROGRAMMED USING ELECTRODES 2 AND 3. SEVEN MONTHS LATER, THE PT LOST STIMULATION AND ALL IMPEDANCES WERE >40,000 OHMS. DESPITE THIS, THE PT WAS SUCCESSFULLY REPROGRAMMED USING ELECTRODES 6 AND 7. THE INS WAS AT END OF LIFE AND WAS BEING REPLACED. AFTER REPLACEMENT, THE IMPEDANCES WERE MEASURED AND ALL WERE >40,000 OHMS AT 3V. THE LEAD CONFIGURATION AND EXTENSION WERE BOTH CHECKED AND CONFIRMED AS CORRECT. THE EXTENSION WAS REMOVED, WIPED WITH A DRY SWAB, AND REINSERTED, BUT THE IMPEDANCES WERE STILL OUT OF RANGE. THE LEAD WAS TESTED WITH A SNAP LID CABLE AND AN EXTERNAL NEUROSTIMULATOR AND THE IMPEDANCES WERE STILL OUT OF RANGE. THE VISIBLE PORTION OF THE EXTENSION WAS EXAMINED AND THERE WERE NO OBVIOUS CUTS OR BREAKS. THE LEAD WAS TESTED AGAIN AND THE PT WAS ABLE TO FEEL STIMULATION USING ELECTRODES 6 AND 7 WHEN THE INS WAS SET TO 1.7V EVEN THOUGH ALL IMPEDANCES WERE OUT OF RANGE. THE PT WAS UNABLE TO FEEL ANY STIMULATION USING ELECTRODES 0-3. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. THE PT WAS NOT INJURED AND WAS RECEIVING THERAPEUTIC BENEFIT. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT # 3007566237201104016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXPLANTED:| LOT# UNK| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007618N| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37702| EXPLANTED:| LEAD: MODEL 3998, LOT# B0467370K