BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3043125 · Received April 9, 2013

    Report

    Report Number
    3006630150-2013-00650
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    July 18, 2012
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICE 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 WAS UNABLE TO CHARGE HER IPG. SEVERAL CHARGING SESSIONS WERE DONE BUT WERE UNSUCCESSFUL. THE PATIENT HAD A NON-DEVICE RELATED PROCEDURE WHEREIN AN EXTERNAL DEFIBRILLATOR WAS USED. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE HER IPG. SEVERAL CHARGING SESSIONS WERE DONE BUT WERE UNSUCCESSFUL. THE PATIENT HAD A NON-DEVICE RELATED PROCEDURE WHEREIN AN EXTERNAL DEFIBRILLATOR WAS USED. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146176 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR