BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 3023572 · Received March 27, 2013

    Report

    Report Number
    2135394-2013-00007
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 24, 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 3 DAYS FOLLOWING THE IMPLANT OF THIS TEMPORARY PACING LEAD, IT STOPPED WORKING. THE PATIENT HAD COMPLETE HEART BLOCK AND ARRESTED AS THIS WAS THE ONLY VENTRICULAR PACING LEAD IN PLACE. ANOTHER TEMPORARY TRANSVENOUS PACING LEAD WAS PLACED AT THE BEDSIDE. THE NEXT DAY A PERMANENT PACEMAKER WAS IMPLANTED, HOWEVER, THE PATIENT DIED A WEEK LATER OF OTHER COMORBIDITIES NOT RELATED TO THE INITIAL TEMPORARY PACING LEAD. IT WAS REPORTED THE BREAK WAS BETWEEN THE ELECTRODES. THE LEAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125745 MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC AFT 6495F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1