BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1080391 · Received July 22, 2008

    Report

    Report Number
    3002158293-2008-00324
    Event Type
    Death
    Date Received
    July 22, 2008
    Date of Event
    June 22, 2008
    Report Date
    July 21, 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

    ELECTRODE BELT. DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO BE FUNCTIONALLY NORMAL. IT WAS RETESTED AND RESTOCKED. THE PT'S BELT GELLED BECAUSE OF NOISE ON THE CHANNELS. THE ELECTRODES WERE MOVING ON THE SKIN AND THE DEVICE ALGORITHM THOUGHT THIS NOISE WAS AN ARRHYTHMIA. THE PT DID NOT RECEIVE A TREATMENT SHOCK, BUT WAS GELLED. IN THE PROCESS OF CHANGING OUT THE ELECTRODE BELT THE PT DIED. HE WAS NOT WEARING THE DEVICE AT THE TIME OF DEATH.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER HUSBAND'S BELT GELLED. SHE SAID THAT HE WAS GETTING OUT OF BED WHEN THE SIREN ALARMS WENT OFF, AND SHE SAID THAT HE DID NOT RESPOND. SHE STATED THE BELT GELLED, BUT A TREATMENT WAS NOT GIVEN. SHE SAID THAT HE FEELS FINE. SHE EVEN TOOK HIS BLOOD PRESSURE AND PULSE RATE (117) TO MAKE SURE. SHE HAS TO GO TO ANOTHER LOCATION TO DOWNLOAD AND WILL DO THAT FIRST THING IN THE MORNING. SUPPORT INSTRUCTED HER HOW TO APPLY THE GEL PACKETS UNTIL HE RECEIVES A NEW BELT. SUPPORT CALLED AT 9:30 AM AND LEFT A MESSAGE ON HER CELL THAT A BELT WILL BE DELIVERED TODAY AND TO FOLLOW-UP TO SEE HOW HE IS DOING. SUPPORT SENT THE PT A NEW BELT AND GARMENT (A05) VIA SAME DAY COURIER. PT'S WIFE CALLED TO SUPPORT TO REPORT THAT SHE DID NOT RECEIVE THE BELT YET. SUPPORT CALLED SHIPPING TO TRACK. SHIPPING REPORTED THAT THEY SPOKE TO LISA AT LYNDEN THIS MORNING AT AROUND 9:30, AND SHE SAID THAT IT WOULD BE DELIVERED AT ANY MOMENT. SUPPORT CALLED PT'S WIFE AT 9:45 AM TO LET HER KNOW THAT THE BELT WOULD BE ARRIVING SHORTLY AND ASKED THAT SHE CALL INTO SUPPORT WHEN SHE RECEIVES IT. AT 2:15 PM, SUPPORT CALLED THE PT'S WIFE. THE WOMAN THAT ANSWERED THE PHONE SAID THAT SHE WAS THE PT'S SISTER-IN-LAW AND THAT THIS WAS NOT A GOOD TIME BECAUSE PT HAD JUST PASSED AWAY. SHIPPING CALLED LYNDEN AT 2:30 PM TO SEE IF THEY HAVE ANY INFO AS TO IF AND WHEN THE BELT ARRIVED AT THE PT'S HOME. SHIPPING REPORTED THAT THE PT'S WIFE SIGNED FOR THE BELT AT 10:45 AM. ON 07-08-08 SUPPORT SPOKE TO THE PTS WIFE. THE NEW ELECTRODE BELT ARRIVED ON THE PREVIOUS MONTH. THE PT'S WIFE REMOVED THE BELT TO SWAP IT OUT AND BATH HIM. THE PT PASSED AWAY IN THE BATH NOT WEARING THE VEST.

    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 74 YR Death