BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1000014 · Received February 18, 2008

    Report

    Report Number
    MW5005538
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    September 19, 2007
    Report Date
    December 16, 2007
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE IRREGULAR HEART RHYTHMS - HAD PACER REPLACED DUE TO LOW BATTERY, STILL HAVING SYMPTOMS WHICH DATE BACK TO 2000. I RECENTLY HAD PACEMAKER REPLACED, DUE TO LOW BATTERY, AND IRREGULAR HEART RHYTHMS BY DR. HE MENTIONED THE PACER LED TO THE HEART COULD BE FRACTURED OR CRACKED AND WAS CONCERNED, BUT LOOKED LIKE OK CONDITION WHEN PROCEDURE WAS DONE. I SAW ON TV COMMERICAL, THEIR COMMERCIAL MEDTRONIC PACER LEADS BEING RECALLED AND WAS CONCERNED BECAUSE I'VE HAD IRREGULAR HEART BEATS THAT'S UN-EXPLAINABLE, OFF AND ON DATING BACK TO 2001 WHEN I HAD MY PACER RE-PROGRAMABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SENSIA S.R. PACEMAKER DTB MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other