BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1082115 · Received July 25, 2008

    Report

    Report Number
    3002158293-2008-00327
    Event Type
    Death
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 24, 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

    DEVICE MANUFACTURE DATE: MONITOR. ELECTRODE BELT - 05/2008. DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR HAS BEEN COMPLETED. IT WAS FOUND TO BE FUNCTIONALLY NORMAL. IT WAS RETESTED AND RESTOCKED. THE ELECTRODE BELT WAS LOST, BUT FROM THE FLAGS LOOKED TO BE FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    IN 2008, A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE HAD BEEN TREATED AND WAS COVERED IN BLUE GEL. HE STATED THAT HE WAS IN BED, WHEN HE WOKE UP SWEATY AND THE "TREATMENT DELIVERED" ALARM WAS SOUNDING. HE STATED THAT HE DID NOT REMEMBER THE EVENT. SUPPORT REQUESTED A DOWNLOAD THAT REVEALED A VALID TREATMENT EVENT. SUPPORT ASKED THE PT TO CONTACT HIS PHYSICIAN AND TO CONTINUE WEARING THE DEVICE. SUPPORT REMINDED PT TO PUT GEL ON THE PADS WHEN THE DEVICE TOLD HIM. SUPPORT RECEIVED AN E-MAIL FROM A LIFECOR PT SERVICES REP (PSR) LATER IN THE DAY THAT STATED THE PT HAD DIED. THE PSR STATED THAT THE PT NEVER WENT TO THE HOSPITAL. THE WIFE STATED THAT HE DID NOT WANT TO GO TO THE HOSPITAL. ON 07/01/08 PSR SPOKE WITH THE PT'S WIFE WHO STATED THAT SHE LEFT THE ROOM FOR APPROX 10 MINUTES AND WHEN SHE RETURNED, THE PT WAS ON THE FLOOR BEING TREATED AGAIN. ON 07/09/08 SUPPORT SPOKE WITH THE PT'S WIFE. SHE STATED THAT THE DEVICE CONTINUED TO TREAT UNTIL THE MEDICS ARRIVED AND CUT THE DEVICE OFF OF HIM. SHE STATED THAT THE MEDICS COULD NOT REVIVE HIM USING AN AED EITHER. THE ELECTRODE BELT WAS LOST SOMEWHERE BETWEEN THE HOSPITAL AND FUNERAL HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death