BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPI ENDOTAC LEAD/CPK TRANSVERSE LEAD

    MDR report key: 28919 · Received August 30, 1995

    Report

    Report Number
    28919
    Event Type
    Injury
    Date Received
    August 30, 1995
    Date of Event
    May 16, 1995
    Report Date
    June 16, 1995
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH AICD IMPLANT DONE ON 10/14/94 FOR V-TACH, V-FIB, MARKED CARDIOMEGELY, AND H/O SUDDEN DEATH. PT WAS RE-ADMITTED 5/16/95 FOR INAPPROPRIATE AICD "SHOCKS." CHEST X-RAY LEAD DISLODGMENT. AICD LEAD REPLACEMENT WAS DONE 5/18/95. PT WAS DISCHARGED IN GOOD CONDITION ON 5/20/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI ENDOTAC LEAD/CPK TRANSVERSE LEAD Implant RATE & MORPHOLOGY-SENSING CARDIOVERSE LEAD LWS CARDIAC PACEMAKERS, INC. 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R