BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2101067 · Received May 24, 2011

    Report

    Report Number
    3006630150-2011-00735
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD (S/N (B)(4)) PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT OF HIGH IMPEDANCE WAS CONFIRMED. THE REPORTED HIGH IMPEDANCE RESULTED FROM THE FRACTURED CABLES AT THE PROXIMAL END OF THE LEAD. THE LEAD HAD A PERMANENT BEND ON IT RIGHT AFTER IT EXITED THE IPG ON THE PROXIMAL END. THE PROXIMAL END HAS HYSOL EPOXY IN IT TO STIFFEN IT. IF AFTER INSERTION INTO THE HEADER, THE LEAD IS GIVEN A TIGHT BEND WHERE THE LEAD EXITS THE IPG, THIS PUTS QUITE A LOT OF TENSION ON THE LEAD CABLES. DEVICE ANALYSIS OF LEAD (S/N (B)(4)) AND THE IPG REVEALED BOTH DEVICES EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50 (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET MODEL # SC-1110-02 (B)(4) DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DURING A REPROGRAMMING SESSION THE PATIENT COMPLAINED OF UNCOMFORTABLE STIMULATION. X-RAYS CONFIRMED LEAD MIGRATION AND THAT 2 CONTACTS HAD HIGH IMPEDANCES. THE PHYSICIAN AND PATIENT HAVE ELECTED TO EXPLANT THE PATIENT'S DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DURING A REPROGRAMMING SESSION THE PATIENT COMPLAINED OF UNCOMFORTABLE STIMULATION. X-RAYS CONFIRMED LEAD MIGRATION AND THAT 2 CONTACTS HAD HIGH IMPEDANCES. THE PHYSICIAN AND PATIENT HAVE ELECTED TO EXPLANT THE PATIENT'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention