BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION®

    MDR report key: 2870364 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02305
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVED THE PATIENT'S DEATH WAS NOT DEVICE OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY DUE TO A MASSIVE HEART ATTACK. NO AVAILABLE INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY DUE TO A MASSIVE HEART ATTACK. NO AVAILABLE INFORMATION YET AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death