BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3895589 · Received June 25, 2014

    Report

    Report Number
    3006630150-2014-01409
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2138-50, SERIAL #: (B)(4), DESCRIPTION: SCS 50CM III LEAD. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. HIGH IMPEDANCE WAS NOTED ON ONE OF THE LEADS DUE TO LEAD FRACTURE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS WERE REPLACED. LEAD FRACTURE WAS CONFIRMED DURING THE PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. HIGH IMPEDANCE WAS NOTED ON ONE OF THE LEADS DUE TO LEAD FRACTURE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS WERE REPLACED. LEAD FRACTURE WAS CONFIRMED DURING THE PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371506 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention