BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 6139647 · Received December 1, 2016

    Report

    Report Number
    3006630150-2016-03484
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8352-50 SERIAL: (B)(4) DESCRIPTION: COVEREDGE X 32, 50 CM 4X8 SURGICAL LEAD. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN INDICATING THAT THE PATIENT'S HEART ATTACK WAS POSSIBLY CAUSED BY COMPLICATIONS FROM ANESTHESIA.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING THE IMPLANT PROCEDURE THE PHYSICIAN BELIEVED THAT THE PATIENT MAY HAVE EXPERIENCED A TRANSIENT ISCHEMIC ATTACK DUE TO SLURRED SPEECH. COMPUTED TOMOGRAPHY (CT) SCAN RESULTS WERE NORMAL. THE PATIENT PASSED AWAY SHORTLY AFTER THE CT SCAN. THE PHYSICIAN BELIEVES THAT THE PATIENT SUFFERED A HEART ATTACK.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING THE IMPLANT PROCEDURE THE PHYSICIAN BELIEVED THAT THE PATIENT MAY HAVE EXPERIENCED A TRANSIENT ISCHEMIC ATTACK DUE TO SLURRED SPEECH. COMPUTED TOMOGRAPHY (CT) SCAN RESULTS WERE NORMAL. THE PATIENT PASSED AWAY SHORTLY AFTER THE CT SCAN. THE PHYSICIAN BELIEVES THAT THE PATIENT SUFFERED A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788576 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death