BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3813336 · Received May 15, 2014

    Report

    Report Number
    3006630150-2014-01076
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE LEAD PASSED MECHANICAL AND VISUAL INSPECTION TESTS PERFORMED. THE RETURNED LEAD WAS ANALYZED AND THE COMPLAINT WAS CONFIRMED. X RAY INSPECTION FOUND THAT THE LEAD BODY WAS FRACTURED BETWEEN CONTACTS #1-#5 IN THE PROXIMAL ARRAY. THE ROOT CAUSE OF THE FRACTURES APPEARS TO HAVE BEEN CAUSED BY FATIGUE COUPLED WITH POSTURAL CHANGES/MOVEMENTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO LEAD MIGRATION. DURING THE REVISION HIGH IMPEDANCES WERE NOTED ON ALL CONTACTS. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289302 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention