BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION NOVI

    MDR report key: 6239038 · Received January 10, 2017

    Report

    Report Number
    3006630150-2017-00042
    Event Type
    Death
    Date Received
    January 10, 2017
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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; MODEL: SC-4316, LOT: 19599199 DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. 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 THAT NO FURTHER INFORMATION CAN BE OBTAINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT STOPPED RESPONDING UNDER ANESTHESIA AND PASSED AWAY TOWARDS THE END OF HER IMPLANT SURGERY. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PATIENT¿S DEATH BUT REPORTED THAT THE PATIENT WAS VERY OLD. THE PHYSICIAN DOES NOT FEEL THE PASSING WAS DEVICE RELATED AND IS NOT SURE IF IT WAS PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT STOPPED RESPONDING UNDER ANESTHESIA AND PASSED AWAY TOWARDS THE END OF HER IMPLANT SURGERY. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PATIENT¿S DEATH BUT REPORTED THAT THE PATIENT WAS VERY OLD. THE PHYSICIAN DOES NOT FEEL THE PASSING WAS DEVICE RELATED AND IS NOT SURE IF IT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20030 PRECISION NOVI SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 NA 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death