BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3160006 · Received June 10, 2013

    Report

    Report Number
    3006630150-2013-01176
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD (SN (B)(4)) WAS FRACTURED. VISUAL INSPECTION REVEALED THE LEAD BODY HAD A PRONOUNCED KINK FROM THE DISTAL END, WHERE THE LEAD APPEARED TO HAVE BEEN SUTURED. ALL CABLES WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITE WAS 1 CM FROM THE CLIK ANCHOR SETSCREW MARK. THIS APPEARED TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. DEVICE EVALUATION INDICATED THAT THE LEAD (SN (B)(4)) PASSED THE VISUAL TEST PERFORMED. THE LEAD EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING GOOD COVERAGE. HIGH IMPEDANCES WERE NOTED ON SEVERAL CONTACTS OF THE LEAD. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEADS WERE REPLACED DUE TO LEAD FRACTURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING GOOD COVERAGE. HIGH IMPEDANCES WERE NOTED ON SEVERAL CONTACTS OF THE LEAD. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEADS WERE REPLACED DUE TO LEAD FRACTURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259296 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention