BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4644056 · Received March 26, 2015

    Report

    Report Number
    3008642652-2015-01374
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    May 30, 2014
    Report Date
    March 13, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR AND ELECTRODE BELT WERE FUNCTIONAL AND ABLE TO DETECT AND TREAT A PATIENT. DEVICE MANUFACTURE DATE AND USAGE OF DEVICE: MONITOR (B)(4): 01/2011- REUSE, ELECTRODE BELT (B)(4): 05/2014- INITIAL USE. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: INAPPROPRIATE DEFIBRILLATION ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION (B)(6). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. THE NURSE OF A (B)(6) YEAR OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS TREATED TWICE. THE LIFEVEST TREATED THE PATIENT TWICE, FIRST AT 1508:01 AND 15:26:35 ON (B)(6) 2014 WHILE AT A REHABILITATION AND NURSING FACILITY. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE NOT USED DURING THE ENTIRE EVENT. THE NURSE REPORTED THAT THE PATIENT COULD NOT PRESS THE RESPONSE BUTTONS DUE TO SEVERE CARPAL TUNNEL SYNDROME. THE PATIENT WAS TAKEN TO THE HOSP AND CONTINUED TO USE THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202081 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O