BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION®

    MDR report key: 3051490 · Received April 10, 2013

    Report

    Report Number
    3006630150-2013-00649
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: SC-2218-50, SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. THE DEVICES WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT PASSED AWAY DURING THE TRIAL IMPLANT PROCEDURE DUE TO CARDIAC ARREST. THERE WERE NO ISSUES IDENTIFIED DURING THAT TRIAL THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE PHYSICIAN BELIEVES THE PATIENT'S DEATH IS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT HAD CO-MORBIDITIES WHICH ARE BELIEVED TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154007 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death