BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3881852 · Received June 18, 2014

    Report

    Report Number
    3006630150-2014-01277
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, IT WAS NOTED THAT THE SURGEON BENT A NEW LEAD THAT WILL BE IMPLANTED TO THE PATIENT BUT THE SURGEON WAS ABLE TO MANAGE TO IMPLANT THE NEW LEAD. POSTOPERATIVELY, THE NEW LEAD SHOWED HIGH IMPEDANCES. REPROGRAMMING WAS DONE BUT IT DID NOT HAVE A GOOD OUTCOME. THE PATIENT UNDERWENT ANOTHER REVISION WHEREIN THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357201 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR