BEUDAMED
    FDA Adverse Event Summary report: N

    BI-V ICD

    MDR report key: 1062523 · Received June 7, 2008

    Report

    Report Number
    1062523
    Date Received
    June 7, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 7, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS A HISTORY OF ATRIAL FIBRILLATION AND NON-ISCHEMIC CARDIOMYOPATHY (NYHA CLASS II) WITH BIVENTRICULAR ICD ( PLACED IN SUBPECTORAL REGION) WHO WAS TRANSFERRED FROM THE OUT SIDE HOSPITAL (OSH) FOR ICD MALFUNCTION. PATIENT REPORTS THAT TWO MONTHS AGO SHE BEGAN ACCUMULATING FLUID IN HER LOWER EXTREMITIES AND ABDOMEN, AND EXPERIENCING ONE-TWO HOUR EPISODES OF PALPITATIONS EVERY EVENING. SHE WENT TO HER PCP FOR EVALUATION. AFTER FAILING MANAGEMENT WITH MEDICATION, SHE WENT TO HER CARDIOLOGIST WHO INTERROGATED HER ICD, AND IT WAS SHOWN TO BE MALFUNCTIONING. IT WAS BELIEVED THAT IT HAD REACHED END OF LIFE, AND SHE WAS ADMITTED TO OSH FOR ICD GENERATOR CHANGE/ SECONDARY TO IT REACHING END OF LIFE. THE GENERATOR WAS CHANGED; AT THAT TIME IT WAS DISCOVERED THAT ONE OF THE LEADS WAS INCORRECTLY POSITIONED. IT IS UNCLEAR IF IT WAS MOVED IN THE PROCESS OF BATTERY CHANGE OR WAS THE CAUSE OF THE PRIOR MALFUNCTION. INTERROGATION OF THE DEVICE AT THAT TIME REVEALED THAT SHE WAS WITHOUT ANY SENSING/PACING BY THE CORONARY SINUS LEAD; IN ADDITION, THE RV LEAD DID NOT SENSE. BOTH LEADS WERE FOUND TO HAVE HIGH IMPEDANCES. PATIENT WAS TRANSFERRED TO THIS HOSPITAL FOR RE-PLACEMENT OF BIVENTRICULAR ICD LEADS IN THE SETTING OF AFIB WITH RVR AT RISK FOR VENTRICULAR TACHYCARDIA/FIBRILLATION.==================== MANUFACTURER RESPONSE FOR LEFT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD======================AWAITING EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-V ICD ICD LWS MEDTRONIC, INC. C154DWK NA
    2 LV LEAD LEAD, ICD LWS MEDTRONIC INC. 4194-78 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CARDIAC DRUGS| CARDIAC DRUGS