BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 2634248 · Received June 25, 2012

    Report

    Report Number
    MW5025976
    Event Type
    Death
    Date Received
    June 25, 2012
    Date of Event
    June 7, 2010
    Report Date
    June 25, 2012
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND HAD AN ADAPTA ADDRL1 IMPLANTED (B)(6) OF 2007. HE HAD PREVIOUSLY HAD A LEAD BREAK AND REPLACED. A PORTION OF THAT LEAD REMAINED IN HIS BODY. HE COMPLAINED IN (B)(6) 2010 THAT SOMETHING DID NOT FEEL RIGHT REGARDING THE PACEMAKER. HE HAD A TESTING ON THE PACEMAKER AND WAS TOLD ALL WAS FINE. IN APR HE HAD A THOROUGH EXAM AND WAS TOLD HE WAS DOING EXTREMELY WELL. ON (B)(6), HE DIED SUDDENLY AFTER A RAPID HEART BEAT OCCURRED. I WOULD BE INTERESTED IF ANYONE HAS EXPERIENCED A SIMILAR SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ADAPTA DR PACEMAKER NVZ MEDTRONIC INC. ADDR:1 001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death