BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ADAPTA DR

    MDR report key: 4603556 · Received March 5, 2015

    Report

    Report Number
    MW5041376
    Event Type
    Death
    Date Received
    March 5, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC ADAPTA DR WAS BEING MONITORED FOR BATTERY CHANGE. HAD MET WITH CARDIOLOGIST REGARDING HUSBAND IN REHAB FOR STRENGTHENING FOLLOWING A LONG BOUT WITH CELLULITIS. CARDIOLOGIST TOLD ME WE HAD TIME MONTHS OF PACING AFTER PACEMAKER REPORTED IT NEEDED REPLACING. WE FELT TOTALLY SAFE WITH THIS REASSURANCE. ON (B)(6) 2014 LEADS TO ATRIA SHUT OFF, SENDING HUSBAND INTO ACUTE PULMONARY EDEMA AND NEW ONSET CONGESTIVE HEART FAILURE. TWO DAYS HOSPITALIZED THEN SENT HOME WITH PHYSICAL THERAPY. PACEMAKER CHECK 2 WEEKS LATER VERIFIED THE LOSS OF POWER TO ATRIA. HUSBAND VERY WEAK. WAS TOLD PACER WOULD LAST AT LEAST 3 MORE MONTHS. I ASKED TO WAIT 2 WEEKS SO THAT HE COULD REGAIN SOME STRENGTH AND RESERVE. CARDIOLOGIST SAID HIS HOPE WOULD BE THAT HUSBAND WOULD RETURN TO PREVIOUS ENERGY LEVEL WITH NEW PACEMAKER. INSTEAD, HUSBAND SLIPPED QUICKLY TOWARD DEATH. THE WEEK HE DIED HIS HEART RATE WAS 40 TO 43 BPM. REPORTED THIS TO CARDIOLOGY TECH. WAS TOLD CARDIOLOGIST WOULD PHONE. NO FURTHER COMMUNICATION. CREMATORY IS SAVING PACEMAKER FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152676 MEDTRONIC ADAPTA DR PACEMAKER NVZ MEDTRONIC ADDR01
    152677 PACEMAKER LEAD ELECTRODO DTB MEDTRONIC 5092-52
    152678 PACEMAKER LEAD ELECTRODO DTB MEDTRONIC 5078-45

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H SERTRALINE| LOW DOSE OXYCODONE| WAS ADMITTED TO HOSPICE AND WAS ACTIVELY DYING| OTC MEDS: PRIOR TO 12/04/2014 HE HAD BEEN TAKING| LEVOTHYROXIN| OXYCODONE.| THIS WAS STOPPED WHEN HE WAS PUT ON 2.5 OF| TYLENOL ARTHRITIS.| TRAMADOL| PRAMIPEXOLE| FLECAINIDE| LONG TERM MEDS WERE COUMADIN| LIQUID MORPHINE WAS STARTED WEEK OF DEATH AS HE| RX MEDS: NEW MEDS WERE COREG AND LISINOPRIL