BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC DEFIBRILLATOR

    MDR report key: 2501100 · Received March 19, 2012

    Report

    Report Number
    MW5024728
    Event Type
    Injury
    Date Received
    March 19, 2012
    Report Date
    March 19, 2012
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC DEFIBRILLATOR - MODEL #694765, SERIAL #(B)(4) - FIRED A TOTAL OF 23 TIMES (B)(6) 2012, 6 TIMES WHILE WAITING IN THE (B)(6) HOSPITAL. (B)(6) WAS NOT RETREATED DURING THIS TIME, EVEN THE ATTENDING PHYSICIAN AND NURSING STAFF WAS AWARE THAT THE DEFIBRILLATOR WAS FIRING. MEDICAL RECORDS FROM (B)(6) HOSPITAL (DR (B)(6)) DEPICT THAT THE MEDTRONIC DEFIBRILLATOR WAS "IN NEED OF REPAIR," "MALFUNCTIONED" AND THAT "A LEAD WIRE NEEDED REPLACED." WHEN (B)(6) ASKED THE HOSPITAL STAFF ABOUT IF THE DEFIBRILLATOR MALFUNCTIONED, NO DEFINITE ANSWERS WERE GIVEN TO (B)(6). RATHER QUESTIONS WERE DISMISSED BY STAFF, YET DOCUMENTED IN MEDICAL RECORDS THAT THE PRODUCT WAS DEFECTIVE. WHO CAN (B)(6) TRUST TO FIND OUT IF THIS DEFIBRILLATOR IS ACTUALLY A RECALLED PRODUCT AND IF IT IS DEFECTIVE. JUST BECAUSE THE SERIAL AND MODEL NUMBERS ARE NOT LISTED AS RECALL, HOW DOES THE US FOOD & DRUG ADMINISTRATION KNOW THAT IT ISN'T A DEFECTIVE MEDTRONIC DEFIBRILLATOR. MULTIPLE SHOCKS CAUSED (B)(6) HEART VALVE TO DECREASE PUMPING BLOOD OUT OF HEART, AND CAUSED FLUID TO BUILD UP IN STOMACH AND OTHER AREAS OF BODY, RESULTING IN HOSPITALIZATION IN (B)(6) HOSPITAL, C/O DR (B)(6). (B)(6) WAS EXTREMELY SWOLLEN FROM FLUID BUILDUP BUT WAS DISCHARGED ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEFIBRILLATOR DEFIBRILLATOR LWS D224VRC 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L