BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3844272 · Received June 2, 2014

    Report

    Report Number
    3006630150-2014-01247
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN USED ELECTROCAUTERY DURING THE REVISION PROCEDURE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE TEST AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE REPORTED COMPLAINTS OF COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND IPG WAS NOT CONFIRMED. DEVICE FUNCTIONALITY WAS NORMAL. NO DISCREPANCIES WERE IDENTIFIED DURING THE TESTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IPG. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IPG. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IPG. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322326 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR