BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2190409 · Received July 25, 2011

    Report

    Report Number
    3007566237-2011-05744
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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

    IMPEDANCES >40,000 OHMS WERE REPORTED. THERE WAS ONE OCTAD LEAD IN THE 0-7 SLOT OF THE SNAP LID. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS SHOWED A VARYING GREATER THAN VALUE. THE SNAP LID HAD BEEN SWITCHED OUT AND IMPEDANCES VARIED. IT WAS SUSPECTED THAT THE PHYSICIAN MAY HAVE CUT PART OF THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED, AND A NEW POCKET SITE WAS CREATED. THE PATIENT PRESENTED TO THE CLINIC "LATER" WITH SWELLING AT THE POCKET SITE. 8-15 ELECTRODE WAS REPROGRAMMED FOR BETTER COVERAGE TO THE LEFT LEG. THE 0-7 ELECTRODE READ >20,000 OHMS, AND A PATIENT FELT A SLIGHT "JOLT" (NO INJURY). THE PHYSICIAN BROUGHT THE PATIENT TO THE OPERATING ROOM TO INSPECT AND ENSURE THE LEAD/EXTENSION CONNECTIONS ON THE 0-7 ELECTRODE WERE DRY. IMPEDANCES WERE THEN WITHIN NORMAL LIMITS AND THE PATIENT WAS RECEIVING GOOD STIMULATION COVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-31, LOT# UNK| EXPLANTED:| IMPLANTED: