BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA VR

    MDR report key: 1674869 · Received May 5, 2010

    Report

    Report Number
    2647346-2010-00150
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE "SINCE HER DEVICE WAS IMPLANTED IN (B) (6) 2010, SHE HAD TWO CARDIAC ARRESTS AND ON BOTH OCCASIONS IT DIDN'T FIRE." HE ALSO ALLEGED "SHE WAS GIVEN CPR TO REVIVE HER THE FIRST TIME AND NEVER GOT A SHOCK". ADDITIONALLY, HE REPORTED THAT DR.(B) (6) HAD TOLD THEM THEY WERE GOING TO DO A "CARDIOVERSION" WHILE SHE WAS AT THE (B) (6) HOSPITAL. HE REPORTED HIS WIFE PASSED AWAY BECAUSE OF THIS "FAULTY DEVICE". HE SAID A NURSE TOLD HIM THE CAUSE OF DEATH WAS "HEART FAILURE" AND THAT THE "HEART STOPPED". BASED ON FOLLOW-UP WITH THE CLINIC, THE PATIENT HAD BEEN SICK FOR QUITE SOME TIME AND HAD BEEN HOSPITALIZED FOR A LONG TIME PRIOR TO GETTING IMPLANTED. ON (B) (6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE NURSE STATED THAT THE PATIENT MISSED HER FIRST DEVICE CHECK. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death