BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3926008 · Received June 30, 2014

    Report

    Report Number
    3008642652-2014-02006
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 31, 2013
    Report Date
    June 30, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN: (B)(4) AND MONITOR SN (B)(4) WAS COMPLETED. THE DEVICE WAS FULLY FUNCTIONAL UPON RECEIPT AT ZOLL. NO PROBLEMS WERE FOUND WITH THE EQUIPMENT. ON (B)(6) 2014, THE PATIENT RECEIVED A TREATMENT AT 16:57:13. THE TREATMENT WAS CAUSED BY ATRIAL FIBRILLATION WITH MOTION ARTIFACT. THE POST-SHOCK RHYTHM WAS ATRIAL FIBRILLATION. THE RESPONSE BUTTONS WERE NOT USED PRIOR TO THE TREATMENT. A SECOND TREATMENT WAS DELIVERED AT 22:46:41. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ATRIAL FIBRILLATION WITH MOTION ARTIFACT. THE POST-SHOCK RHYTHM WAS ATRIAL FIBRILLATION. THE RESPONSE BUTTONS WERE INTERMITTENTLY USED PRIOR TO THE SECOND TREATMENT. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION. ECG MOTION ARTIFACT CONTRIBUTED TO THE ARRHYTHMIA DETECTIONS. DEVICE MANUFACTURER DATE: MONITOR SN: (B)(4), ELECTRODE BELT SN: (B)(4) - 06/01/2013.

    Description of Event or Problem · 1

    THE BROTHER OF A (B)(6) YEAR OLD FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT ON (B)(6) 2014, TO REPORT THAT THE PATIENT HAD BEEN TREATED, FELL DOWN, HIT HER HEAD, AND HURT HER BACK. THE PATIENT WAS ADMITTED TO (B)(6) AND WAS IMPLANTED WITH AN ICD ON (B)(6) 2014. THE PATIENT HAD A PRE-EXISTING BACK INJURY THAT WAS REPORTEDLY EXACERBATED BY HER FALL. THE PATIENT REMAINS IN A REHABILITATION FACILITY FOR WEAKNESS ON ONE SIDE OF HER BODY AND SHE REPORTS SUFFERING FROM HEADACHES. A CT SCAN AND X-RAY WERE INCONCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378674 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R