BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2902389 · Received January 8, 2013

    Report

    Report Number
    3006630150-2013-00009
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO A SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE DUE TO CHARGING DIFFICULTIES. THE PATIENT HAD A GYNECOLOGICAL SURGERY IN WHICH ELECTROCAUTERY WAS USED. 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 WILL UNDERGO AN IPG REPLACEMENT PROCEDURE DUE TO CHARGING DIFFICULTIES. THE PATIENT HAD A GYNECOLOGICAL SURGERY IN WHICH ELECTROCAUTERY WAS USED. 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
    9721 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR