BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4211951 · Received October 29, 2014

    Report

    Report Number
    3006630150-2014-02509
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME. THE DEVICE WAS NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FAST BATTERY DEPLETION. IT WAS NOTED THAT THE PHYSICIAN USED ELECTROCAUTERY DURING THE PATIENT'S PERMANENT IMPLANT. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT 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).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FAST BATTERY DEPLETION. IT WAS NOTED THAT THE PHYSICIAN USED ELECTROCAUTERY DURING THE PATIENT'S PERMANENT IMPLANT. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PHYSICIAN BELIEVED THE IPG DAMAGE WAS DUE TO A NON-DEVICE RELATED CAR ACCIDENT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT 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)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693849 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR