BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3945452 · Received July 21, 2014

    Report

    Report Number
    3006630150-2014-01665
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM).

    Additional Manufacturer Narrative · 1

    SC-2316-70 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD REVEALED MULTIPLE CABLES THAT WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION WAS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. SC-3400-30 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD SPLITTER PASSED VISUAL, ELECTRICAL, MECHANICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. A TEST INFINION LEAD WAS INSERTED INTO THE SPLITTER CONNECTOR WITHOUT ANY ANOMALIES. DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. SEVERAL CONTACTS OF THE LEAD WERE SHOWING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD AND LEAD EXTENSION WERE REPLACED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. SEVERAL CONTACTS OF THE LEAD WERE SHOWING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD AND LEAD EXTENSION WERE REPLACED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425989 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention