BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA

    MDR report key: 7097177 · Received December 7, 2017

    Report

    Report Number
    3006630150-2017-05209
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779902
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8216-50 SERIAL#:(B)(4). DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION DUE TO THE LEAD BEING PLACED UPSIDE DOWN. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875823 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA 08714729779902

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR