BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3930438 · Received July 11, 2014

    Report

    Report Number
    3006630150-2014-01624
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. PATIENT WAS HAPPY WITH STIMULATION GETTING COVERAGE. IT WAS REPORTED THAT IPG WAS NOT HOLDING A CHARGE AND MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS CHARGING THE IPG FREQUENTLY. THE PHYSICIAN RECOMMENDED AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS CHARGING THE IPG FREQUENTLY. THE PHYSICIAN RECOMMENDED AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406152 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR