BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTAK PRX

    MDR report key: 18944 · Received January 12, 1995

    Report

    Report Number
    MW1004743
    Event Type
    Other
    Date Received
    January 12, 1995
    Date of Event
    November 15, 1994
    Report Date
    December 19, 1994
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A DEFIBRILLATOR INSERTED 11/9/94. PT PRESENTED TO ER 11/15/94 WITH CHEST PAIN AFTER HAVING LEFT HIS AICD DEFIBRILLATE HIM. ON CHEST X-RAY THE RADIOLOGIST NOTES THAT THE DEFIBRILLATOR WIRE HAS A BREAK IN IT AT THE LEVEL OF THE SUPERIOR VENA CAVA. THIS PT DID EXPIRE 11/15/94. INTIALLY THE AICD WAS INTERMITTENTLY FIRING/CAPTURING APPROPRIATELY. LATER THE PAGER WOULD NOT CAPTURE. THE PT WAS PROBABLY IN CARDIOGENIC SHOCK AS WELL AND IT IS UNKNOWN IF HIS DEATH IS DIRECTLY RELATED TO THE BROKEN PACER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX Implant IMPLANTED CARDIAC PACEMAKER/DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC. 1705

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other