BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 6109088 · Received November 17, 2016

    Report

    Report Number
    3008829311-2016-00219
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ST. JUDE MEDICAL - SPINAL MODULATION
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 3008829311-2016-00218. THE PATIENT HAS BILATERAL LEADS IMPLANTED AT L1 AS PART OF THEIR AXIUM NEUROSTIMULATOR SYSTEM. IT WAS REPORTED THE PATIENT (B)(6) SUFFERED TWO FALLS AFTER IMPLANT AND IS EXPERIENCING INEFFECTIVE STIMULATION. ADDITIONALLY, THE PATIENT EXPERIENCED PAINFUL STIMULATION IN THE RIGHT FLANK AND NO PAIN RELIEF WHEN UTILIZING THE RIGHT SIDE IMPLANTED LEAD. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE THERAPY. X-RAYS WERE TAKEN AND INDICATED ONE OF THE LEADS HAD MIGRATED. SURGICAL INTERVENTION MAY TAKE PLACE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761439 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ST. JUDE MEDICAL - SPINAL MODULATION MN20450-90A AB2054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other