BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION MONTAGE

    MDR report key: 6426377 · Received March 22, 2017

    Report

    Report Number
    3006630150-2017-00866
    Event Type
    Death
    Date Received
    March 22, 2017
    Date of Event
    February 22, 2017
    Report Date
    March 2, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2408-56, SERIAL # (B)(4), DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM. MODEL #: SC-4319, LOT # 19541305, DESCRIPTION: CLIK X MRI ANCHOR. 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 PASSED AWAY. THE PHYSICIAN BELIEVES THE PATIENT¿S PASSING WAS NOT STIMULATOR RELATED. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206029 PRECISION MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Death