BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3052854 · Received April 11, 2013

    Report

    Report Number
    2649622-2013-04932
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    June 15, 2012
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REPORTED AS DECEASED EIGHT DAYS FOLLOWING THE IMPLANT PROCEDURE. IT WAS REPORTED THAT THE PATIENT SUFFERED REVERSED CARDIOPULMONARY ARREST ASSOCIATED TO AN ABSENCE OF PACEMAKER SIGNAL. EVALUATION BY THE PHYSICIAN LATER REPORTED NO EVIDENCED PROBLEM WITH THE DEVICE. ON THE FIFTH POST-OPERATIVE DAY, NEW OCCURRENCES RELATED TO THE DEVICE FOLLOWED BY THE PATIENT DEATH WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154524 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 MO Death