BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2003994 · Received March 1, 2011

    Report

    Report Number
    3006630150-2011-00269
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    September 29, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2218-50 SERIAL#: (B)(4) & (B)(4) DESCRIPTION: ENH ST LD KIT, 50 CM THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS PERFORMED. ADDITIONAL TESTING DETERMINED DAMAGE TO ANALOG IC BY ELECTROCAUTERY. THE PATIENT CONFIRMED THAT A SURGERY WAS PERFORMED WHERE ELECTROCAUTERY WAS USED. THE EXPLANTED LEADS EXHIBIT NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT OF INADEQUATE COVERAGE WAS RECEIVED. THE PATIENT WAS OFFERED REPROGRAMMING BY BSN BUT THE PATIENT ELECTED TO BE EXPLANTED. THE PATIENT NEEDED TO GET SOME MRIS FOR NON DEVICE RELATED REASONS. THE DEVICE WAS RETURNED TO BSN AND DURING DEVICE ANALYSIS IT WAS DETERMINED THAT THE IPG'S ANALOG IC WAS DAMAGED BY THE ELECTROCAUTERY USED PRIOR THE EXPLANT OF THE DEVICE. THE CURRENT COMPANY LABELING WARNS AGAINST THE USE OF ELECTROCAUTERY, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention