BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1526143 · Received November 9, 2009

    Report

    Report Number
    3002158293-2009-00779
    Event Type
    Other
    Date Received
    November 9, 2009
    Date of Event
    September 25, 2009
    Report Date
    November 6, 2009
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PATIENT'S RECORD WAS EXAMINED. ON 08/27, (B)(6) WAS SCHEDULED TO PICK UP A 1LB PACKAGE FOR AN ALLEGEDLY DEFECTIVE ELECTRODE BELT THAT HAD BEEN REPLACED. ON 09/15, THE PATIENT'S DAUGHTER CONTACTED THE ACCOUNT COORDINATOR TO ASK FOR TWO LABELS BECAUSE SHE HAD TWO BOXES TO SHIP BACK TO LIFECOR. THE ACCOUNT COORDINATOR DID NOT ASK THE DAUGHTER WHY SHE HAD TWO BOXES TO SEND BACK TO LIFECOR. THE AC DID NOT END USE AND NEVER SUGGESTED THE PATIENT RETURN THE SYSTEM. THE SYSTEM AND THE ALLEGEDLY DEFECTIVE ELECTRODE BELT STILL HAVE NOT BEEN RETURNED TO LIFECOR. CONCLUSIONS: NOISE DETECTED BY THE DEVICE MAY CORRESPOND TO THE TWO DEFIBRILLATIONS BY HOSPITAL STAFF. THE DEVICE WAS FUNCTIONING PROPERLY AND DID NOT DETECT ANY TREATABLE ARRHYTHMIA DURING THE PERIOD THE VEST WAS BEING WORN. IF THE PATIENT WAS IN VENTRICULAR FIBRILLATION DURING THE TIME OF USE, IT APPEARS EITHER THAT THE RATE OF CARDIAC SIGNAL WAS SLOWER THAN THE THRESHOLD FOR TREATMENT OR THAT THE SIGNAL AMPLITUDE WAS BELOW THE THRESHOLD FOR DETECTION.

    Description of Event or Problem · 1

    THE TERRITORY MANAGER (TM) OF A (B)(6), FEMALE, PATIENT, CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THE PATIENT HAD SUFFERED AN EXTENDED VT INCIDENT WHILE NOT WEARING THE DEVICE. THE PATIENT WAS EXPECTED TO NOT PULL THROUGH. THE PATIENT'S DAUGHTER TOLD THE DOCTOR THAT LIFECOR REQUESTED THE PATIENT RETURN THE SYSTEM AND THAT IS WHY THE PATIENT WAS NOT WEARING THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization