BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 21767719 · Received April 3, 2025

    Report

    Report Number
    3008642652-2025-03506
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 3, 2025
    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

    N/A

    Description of Event or Problem · 0

    INVESTIGATION INTO MEDWATCH REPORT MW5166217 IS AS FOLLOWS: ANALYSIS OF THIS EVENT INDICATES THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK ON 2/7/2025, WHICH WAS ALREADY REPORTED TO FDA UNDER MDR NUMBER 3008642652-2025-01924-00. THERE WAS NO KNOWN REPORTED INJURY RELATED ¿SINGE/BURN MARKS¿. BY DESIGN, BLUE GEL IS EXPECTED TO BE DELIVERED PRIOR TO A DEFIBRILLATION EVENT; NOT AFTER SHOCKING THE PATIENT. SUBSEQUENTLY, A SEPARATE COMPLAINT WAS LOGGED FOR THE SAME PATIENT, INDICATING A RASH OR SKIN IRRITATION. FOLLOW UP WITH THE PATIENT ON (B)(6) 2025 INDICATED THAT THE IRRITATION WAS DUE TO THE GARMENT CLASP, UNRELATED TO THE DEFIBRILLATION SHOCK OR THE DEFIBRILLATION PADS, AND WAS HEALING ON ITS OWN WHERE MEDICAL ATTENTION WAS NOT REQUIRED. CONCLUSION: THE ALLEGATION FOR THE PATIENT SUSTAINING ¿SINGE/BURN MARKS AS A RESULT OF NO GEL RELEASED PRIOR TO SHOCK¿ WAS NOT ASSOCIATED WITH THE DEFIBRILLATION EVENT. THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE IS NO INDICATION THAT THE USE OF THE DEVICE WAS LIFE THREATENING OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE REPORTED INJURY IN THE MEDWATCH REPORT MW5166217 IS NOT A REPORTABLE EVENT. CLOSING THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848309 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown