BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2250712 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07747
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    March 31, 2011
    Report Date
    November 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD MODEL 3389, LOT # UNKNOWN, DETERMINED THE PRODUCT WAS SEGMENTED WITH NO SIGNIFICANT ANOMALIES. THE PRODUCT SEGMENTATION WAS SUSPECTED EXPLANT DAMAGE. THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF LEAD MODEL 3389, LOT # UNKNOWN DETERMINED NO SIGNIFICANT ANOMALIES. THE BODY INSULATION WAS CUT THROUGH AND THE LEAD WAS SEGMENTED (SUSPECTED EXPLANT DAMAGE). THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LACK OF STIMULATION ON BOTH SIDES. AN X-RAY REVEALED THAT THE RIGHT EXTENSION WAS BROKEN. ELECTRODE IMPEDANCES WERE TESTED IN THE OPERATING ROOM AND IT WAS FOUND THAT ALL IMPEDANCES ON THE LEFT ELECTRODE WERE ABOVE 4,000 OHMS AND ELECTRODE ONE ON THE RIGHT CHANNEL WAS ABOVE 4,000 OHMS. THE EXTENSIONS WERE CUT (PREVIOUSLY CONNECTED TO A KINETRA) AND LEFT IMPLANTED WHILE THE HCP DECIDED WHAT TO DO. IT WAS REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # UNK| IMPLANTED:| EXTENSION: MODEL 7482, LOT # UNK| EXPLANTED: