BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12520531 · Received September 23, 2021

    Report

    Report Number
    3008642652-2021-08406
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 23, 2021
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    **UPDATED THE MONITOR AND ELECTRODE BELT SNS. MONITOR, FROM 07162194 TO 07009751. ELECTRODE BELT FROM 59051598 TO 59134926** THE MONITOR (B)(6) AND ELECTRODE BELT SN 59134926 HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL G960083 (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). 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. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY. THE MONITOR (B)(6) AND ELECTRODE BELT SN 59051598 HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL G960083 (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). 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. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 0

    SUPPLEMENT SENT 09/23/2021. H10, UPDATED THE MONITOR AND ELECTRODE BELT SNS. MONITOR, FROM 07162194 TO 07009751. ELECTRODE BELT FROM 59051598 TO 59134926. THE PATIENT WAS INAPPROPRIATELY TREATED ONE TIME BY THE LIFEVEST. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. SUPRAVENTRICULAR TACHYCARDIA (SVT) CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. NO INJURY WAS REPORTED FROM THE TREATMENT. IT IS UNKNOWN IF THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT ENDED USE OF THE LIFEVEST. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL (B)(4) (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). 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. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    THE PATIENT WAS INAPPROPRIATELY TREATED ONE TIME BY THE LIFEVEST. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. SUPRAVENTRICULAR TACHYCARDIA (SVT) CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. NO INJURY WAS REPORTED FROM THE TREATMENT. IT IS UNKNOWN IF THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT ENDED USE OF THE LIFEVEST. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416127 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other