BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4762426 · Received May 6, 2015

    Report

    Report Number
    3008642652-2015-02752
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    March 1, 2014
    Report Date
    April 30, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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 BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND BELT WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT A PATIENT. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4); ELECTRODE BELT SN (B)(4): 05/2012. INAPPROPRIATE DEFIBRILLATIONS 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. (B)(4). 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. A GERMAN DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PATIENT WAS TREATED. THE DISTRIBUTOR REPORTED THAT THE PATIENT WAS AT THE HOSPITAL AT THE TIME AND A NURSE AND DOCTOR WERE PRESENT. THEY REPORTED THAT THE PATIENT WAS CONSCIOUS AND PRESSED THE RESPONSE BUTTONS REPEATEDLY. BECAUSE OF THE ONGOING ALARMS THE PATIENT PANICKED AND THE PHYSICIAN DECIDED TO SEDATE THE PATIENT AND THEN THE DEVICE TREATED THE PATIENT. A REVIEW OF THE EVENT INDICATES THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. SVT AT 152-163 BPM CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY MORE THAN A MINUTE BEFORE THE TREATMENT, BUT NOT IMMEDIATELY PRIOR TO THE PULSE DELIVERY. THE PATIENT CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296758 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O