BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2951129 · Received February 8, 2013

    Report

    Report Number
    3006630150-2013-00236
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02 SERIAL #: (B)(4) DESCRIPTION: PRECISION IMPLANTABLE PULSE MODEL #: SC-3400-30 SERIAL #: (B)(4) DESCRIPTION: 30 CM SPLITTER KIT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TESTS PERFORMED. VISUAL AND X-RAY INSPECTION REVEALED ALL CABLES OF THE INFINION LEAD WERE FRACTURED 1CM FROM THE CLIK ANCHOR SITE. FRACTURED CABLES ARE THE ROOT CAUSE OF THE HIGH IMPEDANCES. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE, OPERATIONAL ENVIRONMENT AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. IPG PASSED ALL CIS TESTING. DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. DEVICE EVALUATION INDICATED THAT THE SPLITTER PASSED VISUAL, ELECTRICAL, MECHANICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. SPLITTER PASSED ALL CIS TESTING. DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. DEVICE EVALUATION INDICATED THAT THE ANCHORS PASSED VISUAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. ANCHOR EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE CONTACTS. THE WHOLE SYSTEM WAS EXPLANTED AND THE PATIENT WAS DOING FINE POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE CONTACTS. THE WHOLE SYSTEM WAS EXPLANTED AND THE PATIENT WAS DOING FINE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54082 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR