BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3781353 · Received April 30, 2014

    Report

    Report Number
    3006630150-2014-00904
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. BATTERY DEPLETION RATE WITH STIMULATION OFF WAS WITHIN THE NORMAL RANGE. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE AND THE IPG WAS NOT WORKING. THE PATIENT HAD PREVIOUS MULTIPLE SURGERIES WHEREIN ELECTROCAUTERY WAS USED. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (B)(6).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE AND THE IPG WAS NOT WORKING. THE PATIENT HAD PREVIOUS MULTIPLE SURGERIES WHEREIN ELECTROCAUTERY WAS USED. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259064 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR