BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2843093 · Received November 21, 2012

    Report

    Report Number
    3006630150-2012-02177
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE IPG 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING ITS CHARGE. PREMATURE BATTERY DEPLETION WAS SUSPECTED DUE TO ELECTROCAUTERY WAS BEING USED DURING A NON-DEVICE RELATED SURGERY. THE PHYSICIAN ADVISED THE PATIENT FOR AN IPG REPLACEMENT; HOWEVER, THE PATIENT DECIDED NOT TO UNDERGO A POCKET REVISION. 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 (B)(4)).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING ITS CHARGE. PREMATURE BATTERY DEPLETION WAS SUSPECTED DUE TO ELECTROCAUTERY WAS BEING USED DURING A NON-DEVICE RELATED SURGERY. THE PHYSICIAN ADVISED THE PATIENT FOR AN IPG REPLACEMENT; HOWEVER, THE PATIENT DECIDED NOT TO UNDERGO A POCKET REVISION. 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
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR