BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARQUIS VR

    MDR report key: 1798386 · Received August 13, 2010

    Report

    Report Number
    2647346-2010-00485
    Event Type
    Death
    Date Received
    August 13, 2010
    Date of Event
    May 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY (B)(4) PRELIMINARY ANALYSIS REPORTED THE DEVICE HAD NO TELEMETRY AND NO PACING OUTPUT. FURTHER ANALYSIS REVEALED THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THERE IS NO EVIDENCE TO INDICATE THE DEPLETION WAS ANYTHING OTHER THAN NORMAL. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED. UNDER NOMINAL SETTING THE EXPECTED LONGEVITY IS AN APPROXIMATE MATCH TO THE TIME THE DEVICE WAS IMPLANTED. SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD, THERE IS NO WAY TO CONFIRM THIS RESULT. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THAT ON (B)(6) 2010, HE RECEIVED SHOCK THAT "KNOCKED HIM OUT OF BED." PATIENT BEING SEEN FOR FIRST TIME SINCE IMPLANT IN 2003. DEVICE UNABLE TO BE INTERROGATED- CAN'T GET TELEMETRY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THE PATIENT DIED 19 DAYS AFTER DEVICE EXPLANT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED PATIENT ADMITTED TO HOSPITAL (B)(6) 2010 AFTER CARDIAC ARREST FROM DIARRHEA INDUCED HYPOTENSION. PATIENT WAS RESUSCITATED AND TO HAVE GI CONSULT, BUT THE NEXT DAY, DEVELOPED HYPOTENSION, HYPOXIA, AND BECAME UNRESPONSIVE. AFTER PROLONGED RESUSITATION, THE PATIENT DIED WITH FINAL DIAGNOSIS OF DILATED ISCHEMIC CARDIOMYOPATHY WITH NEW ONSET AFIB, RECURRENT VT AND EMD, ACUTE AND CHRONIC RENAL INSUFFICIENCY, DIARRHEA UNCERTAIN ETIOLOGY RESULTING IN HYPOTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT ON (B)(6)2010, HE RECEIVED A SHOCK THAT "KNOCKED HIM OUT OF BED." PATIENT BEING SEEN FOR THE FIRST TIME SINCE IMPLANT IN 2003. DEVICE UNABLE TO BE INTERROGATED- CAN'T GET TELEMETRY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THE PATIENT DIED 19 DAYS AFTER DEVICE EXPLANT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7230CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death