BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION

    MDR report key: 8613606 · Received May 15, 2019

    Report

    Report Number
    3006630150-2019-02277
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE NUMBER 11023461, UPN (B)(4), MODEL SC-8216-50, SERIAL (B)(4). 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406577 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 15929530 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death