BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 6991476 · Received October 31, 2017

    Report

    Report Number
    3006630150-2017-04392
    Event Type
    Death
    Date Received
    October 31, 2017
    Date of Event
    September 17, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: SC-8216-50 SERIAL/LOT: (B)(4). DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM 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 AND STERILIZATION 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 DUE TO A PULMONARY EMBOLISM. THE PATIENT DEATH WAS REPORTED AS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769769 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death