BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1001902 · Received February 21, 2008

    Report

    Report Number
    3002158293-2008-00076
    Event Type
    Death
    Date Received
    February 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 1, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE DEVICE IN QUESTION WAS NOT RETURNED AND HAS NOT BEEN DOWNLOADED. NO NEW INFO HAS BEEN LEARNED FROM THE FAMILY. A SUPPLEMENTAL REPORT WILL BE WRITTEN AS SOON AS THE EQUIPMENT IS RETURNED TO LIFECOR AND EVALUATED.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT IN 2008, TO REPORT THAT HER HUSBAND PASSED AWAY LAST EVENING FROM VENTRICULAR TACHYCARDIA (VT), AND THE SYS DID NOT ALARM OR SAVE HIM. SHE DID NOT HAVE A LOT OF DETAILS. SUPPORT ASKED IF SHE WAS GIVEN AN EXACT HEART RATE AND EXPLAINED THE DR-SET THRESHOLDS TO HER. SUPPORT ASKED FOR A DOWNLOAD SO THAT WE COULD SEE IF THE DEVICE RECORDED ANYTHING. SHE STATED THAT SHE WAS TOO BUSY AT THE MOMENT AND COULD NOT. PT WAS IN THE HOSP WHEN HE PASSED AND HE WAS ATTACHED TO THEIR MONITORS AS WELL. WHEN SUPPORT ASKED IF THE HOSP STAFF TRIED ANYTHING, SHE RESPONDED THAT "YES, OF COURSE THEY DID." BUT SHE REFUSED TO ELABORATE ANY FURTHER. SUPPORT ASKED THE LIFECOR ACCOUNT COORD (AC) TO CONTACT THE PRESCRIBING DR AS WELL AS THE HOSP TO GET MORE DETAILS IF POSSIBLE. THE AC TALKED TO THE PT'S DR TWO DAYS LATER, BUT THE DR DID NOT HAVE ANY KNOWLEDGE ABOUT THE PT'S HOSP STAY OR THE SITUATION SURROUNDING IT. HE HAD TRIED TO CONTACT THE PT'S WIFE BUT WAS NOT SUCCESSFUL. IF HE FOUND OUT MORE AND THE PT'S WIFE GAVE HIM PERMISSION TO DO SO, HE WAS GOING TO THEN CONTACT LIFECOR WITH FURTHER INFO. THE PT'S WIFE CONTACTED THE AC IN 2008. SHE IS GOING TO THE HOSP HERSELF THIS AFTERNOON TO REQUEST THE MEDICAL REPORT FROM HER HUSBAND'S DEATH. SHE ASKED IF WE COULD SEND HER THE REPORT FROM THE LIFEVEST AT THE TIME OF DEATH. I EXPLAINED THAT WE NEED THE EQUIPMENT BACK IN ORDER TO DOWNLOAD THE INFO TO FIND THAT OUT. SHE STATED HER HUSBAND WAS IN THE ER AT THE TIME AND SHE IS NOT BLAMING US FOR HIS DEATH, SINCE THE HOSP COULDN'T DO ANYTHING FOR HIM EITHER. SHE JUST WANTS CLOSURE. THE AC EXPLAINED THE SOONER LIFECOR REC'D HIS SYS AND THE DOCUMENTS FROM THE HOSP SENT OVER, THE SOONER LIFECOR COULD GIVE HER SOME ANSWERS. SHE SAID SHE WOULD SEND THE SYS BACK AS SOON AS POSSIBLE. THE AC CALLED THE PT'S WIFE THE FOLLOWING MONTH. SHE STATED THAT SHE REC'D THE MEDICAL REPORT THIS MORNING. SHE WAS SENDING IT TO PT'S PHYSICIAN NEXT WEEK. SHE WAS GOING TO SEE AN ATTY THE FOLLOWING WEEK AS WELL. SHE STATED SHE WOULD SEND THE REPORT AND THE SYS BACK AFTER SHE SPEAKS WITH THE ATTY. THE AC TRIED AGAIN TO EXPLAIN THE IMPORTANCE OF US GETTING THE SYS BACK, HOWEVER, SHE WAS VERY ADAMANT ABOUT NOT RETURNING IT UNTIL AFTER SHE SPEAKS TO HER ATTY. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE AC, THE LIFECOR TERRITORY MGR AND LIFECOR CUSTOMER SUPPORT TO GET THE SYS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death