BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4762480 · Received May 6, 2015

    Report

    Report Number
    3008642652-2015-02772
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    January 18, 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
    MI, US
    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 FUNCTIONAL AND ABLE TO DETECT AND TREAT A PATIENT. DEVICE MANUFACTURE DATE. MONITOR SN (B)(4): 12/2011. ELECTRODE BELT SN (B)(4): 06/2007. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: 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. AN (B)(6) FEMALE PATIENT NOTIFIED A ZOLL PATIENT SERVICE REPRESENTATIVE THAT SHE WAS TREATED. THE PATIENT REPORTED THAT SHE WAS NOT FEELING SYMPTOMATIC AND DID NOT GET TO THE RESPONSE BUTTONS IN TIME. THE PATIENT REPORTED THAT SHE WAS IN BED AND HAD THE MONITOR UNDER THE COVERS. SHE HEARD THE ALARMS BUT WAS UNABLE TO GET THE BEDDING OUT OF THE WAY IN TIME. A REVIEW OF THE EVENT INDICATES THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF TWO TREATMENTS. SVT AT 212 - 226 BPM CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE PRESSED BRIEFLY BEFORE AND AFTER THE SECOND TREATMENT, BUT NOT IMMEDIATELY PRIOR TO THE PULSE DELIVERY. THERE WAS NO INDICATION THAT THE PATIENT SOUGHT MEDICAL ATTENTION AFTER THE TREATMENT. THE PATIENT CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298402 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| O