BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3072514 · Received April 23, 2013

    Report

    Report Number
    2649622-2013-05310
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPT(S) FOR ADDITIONAL INFORMATION FROM THE DOCTOR'S OFFICE WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID (B)(4), IMPLANTED: (B)(6) 2003; PRODUCT ID (B)(4), IMPLANTED: (B)(6) 2012. (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Description of Event or Problem · 1

    A PATIENT IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REPORTED AS DECEASED. THE PATIENT WAS REPORTED AS DECEASED SEVEN MONTHS POST IMPLANT OF THE IPG. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175337 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death