BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4262494 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-04122
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    March 20, 2011
    Report Date
    November 13, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY. DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE BOTH FULLY FUNCTIONAL UPON RECEIPT. MONITOR SN (B)(4): (B)(6) 2009 (REUSE). ELECTRODE BELTS SN (B)(4): (B)(6) 2010 (REUSE).

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. ZOLL CUSTOMER SUPPORT WAS ATTEMPTING FOLLOW UP WITH A (B)(6) YEAR OLD PT FOR AN UNRELATED ISSUES, WHEN THE PT'S FIANCE REPORTED THAT THE PT PASSED AWAY ON (B)(6) 2011. THE (B)(6) YEAR OLD MALE PT'S FIANCE REPORTED THAT THE PT WAS AT HIS MOTHER'S HOUSE WHEN HE PASSED. ZOLL CUSTOMER SUPPORT CONTACTED THE PT'S MOTHER WHO REPORTED THAT THE MONITOR DID ALARM AND "DID WHAT IT WAS SUPPOSED TO DO," BUT THE PT STILL PASSED AWAY. REVIEW OF THE PT'S FLAGS AND ECG STRIPS INDICATES THE PT RECEIVED TWO DEFIBRILLATIONS THE DAY OF HIS DEATH. THE PT WAS APPROPRIATELY TREATED FOR VF AT 18:12:28. THE POST SHOCK RHYTHM WAS BRADYCARDIA. THE PT RECEIVED A SECOND DEFIBRILLATION AT 18:36:53. DUAL-LEAD SIGNAL ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE USED EXTENSIVELY IN EARLIER DETECTIONS BUT WERE NOT USED PRIOR TO EITHER TREATMENT. THE ELECTRODE BELT WAS DISCONNECTED AT 18:37:06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738847 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death