BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2233578 · Received September 2, 2011

    Report

    Report Number
    3006630150-2011-01349
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY DEPLETION RATE AT THE TIME OF THE ANALYSIS MEASURED ABOVE THE TYPICAL RANGE. BECAUSE THE IPG HAD BEEN EXPLANTED WITH THE USE OF AN ELECTROCAUTERY, THE DEVICE CHARACTERISTICS MIGHT HAVE BEEN CHANGED, AND THE CURRENT STATE WILL BE LESS RELEVANT TO THE COMPLAINT. HOWEVER, THE DEVICE PROFILE CONFIRMED THAT THE DEVICE HAD BEEN DEPLETED EXCESSIVELY JUST AFTER THE IMPLANT PROCEDURE. TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL IS IMPOSSIBLE SINCE BOTH ANALOG/DIGITAL IC ARE COVERED IN GLOB TOP. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS. THE TIMING OF THE ANOMALY SUGGESTS THAT THE IPG HAD BEEN EXPOSED TO AN ENVIRONMENT SIMILAR TO THE ELECTROCAUTERY USAGE DURING THE IMPLANT PROCEDURE. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABEL WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL 9055940-001 REV. AB).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING. A BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT'S IPG WAS REPLACED AND THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING. A BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT'S IPG WAS REPLACED AND THE PATIENT IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention