BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1852150 · Received September 29, 2010

    Report

    Report Number
    3007566237-2010-07437
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THEY COULD NOT INSERT THE EXTENSION LEAD INTO THE BATTERY ON ONE SIDE. IT WAS NOTED THAT "SOMETHING WAS INTERNALLY BLOCKING IT". WHEN A NEW BATTERY WAS USED IT INSERTED WITHOUT PROBLEMS. THERE WAS NO PT PROBLEM. ADDITIONAL INFO WILL BE PROVIDED WHEN IT 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 IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| LOT# NKM704589H