BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL CORD STIMULATION LEAD

    MDR report key: 2063766 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02836
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    January 1, 2009
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PREVIOUSLY REPORTED "THE PATIENT UNDERWENT A POCKET REVISION SHORTLY AFTER IMPLANT IN 2009. THE INS WAS MOVED FROM THE LOWER KIDNEY AREA TO LOWER RIB AREA ON POSTERIOR SIDE" NO LONGER APPLIES TO THIS EVENT AS IT WAS FOUND TO BETTER ASSOCIATE WITH THE EVENTS CAPTURED IN MANUFACTURER REPORT #3004209178-2016-02797, 3004209178-2016-02798, AND 3004209178-2016-02801. DEVICE CHANGED TO LEAD TO BETTER CAPTURE THIS EVENT/LEAD REVISION. (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT A POCKET REVISION SHORTLY AFTER IMPLANT IN 2009. THE INS WAS MOVED FROM THE LOWER KIDNEY AREA TO LOWER RIB AREA ON POSTERIOR SIDE. HIS CURRENT ISSUE WAS "POSITIONAL STIMULATION" WHEN HE TURNED HIS HEAD. A LEAD REVISION WAS SCHEDULED FOR (B)(6). AN ADD'L LEAD MAY BE ADDED OR REPLACED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATION LEAD LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention STIM ACCESSORY: MODEL 3550-29, LOT# N181103| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136828N| EXPLANTED:| IMPLANTED:| IMPLANTED: