BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

    MDR report key: 3023588 · Received March 27, 2013

    Report

    Report Number
    2135394-2013-00006
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC AFT
    Product Code
    LDF
    PMA / PMN Number
    K012460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT NUMBER WAS PROVIDED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS FOLLOWING THE IMPLANT OF THIS TEMPORARY PACING LEAD, THE LEAD STOPPED WORKING. THE PATIENT HAD COMPLETE HEART BLOCK AND ARRESTED AS THIS WAS THE ONLY VENTRICULAR PACING LEAD IN PLACE. A TEMPORARY TRANSVENOUS PACING LEAD WAS PLACED AT THE BEDSIDE WHEN EXTERNAL PACING WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT CPR FOR 45 MINUTES WHILE THE LEAD WAS BEING PLACED. THE NEXT DAY A PERMANENT PACEMAKER WAS IMPLANTED, HOWEVER, THE PATIENT DIED A COUPLE OF DAYS LATER DUE TO ANOXIC BRAIN INJURY WHICH OCCURRED DURING CPR. THE FAMILY MADE THE DECISION TO WITHDRAW LIFE SUPPORT. AN AUTOPSY WAS PERFORMED, HOWEVER, THE PHYSICIAN HAS NOT RECEIVED THE AUTOPSY REPORT. IT WAS REPORTED THE BREAK WAS BETWEEN THE ELECTRODES. THE LEAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127236 TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC AFT 6495 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1