BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2230568 · Received August 12, 2011

    Report

    Report Number
    3007566237-2011-06300
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SUCCESSFUL TRIAL AND WENT INTO SURGERY FOR A BATTERY IMPLANT. ALL IMPEDANCES WERE CHECKED IN SURGERY AND WERE ALL IN RANGE. WHEN THE PT WAS PROGRAMMED OUT OF SURGERY OUT OF RANGE IMPEDANCES WERE MEASURED. ADDITIONALLY, THE PT FELT NO STIMULATION. THE PT THEN HAD A REVISION, THE LEAD WAS TESTED ON THE TABLE, NO STIMULATION OCCURRED. THE LEAD WAS REMOVED AND REPLACED WITH ANOTHER LEAD. THE PT WAS REPORTEDLY SATISFIED WITH STIMULATION AFTER THE LEAD REPLACEMENT.

    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:| IMPLANTED:| LEAD: MODEL 3888, LOT # UNK