BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1950360 · Received December 14, 2010

    Report

    Report Number
    3007566237-2010-10447
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A WORSENING OF HIS MOTOR SYMPTOMS. THE LEAD IMPEDANCES WERE ABNORMAL, AND ON X-RAY, THE LEAD LOOKED FRACTURED. REPLACEMENT OF THE LEAD WAS PLANNED. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 LEAD: MODEL 3389, LOT # UNK| IMPLANTED:| EXPLANTED: