BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3340125 · Received September 10, 2013

    Report

    Report Number
    2938836-2013-06652
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    June 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT DEVICE UPGRADE DUE TO NORMAL ERI, AFTER CLOSING THE POCKET, DFT TESTING WAS UNSUCCESSFUL IN RESCUING THE PATIENT AT 20J. CHARGES AT 25J AND 37J WERE ABORTED AND PATIENT WAS EXTERNALLY RESCUED. THE ICD SHOWED AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE. ADDITIONAL DFT TESTING WAS ALSO UNSUCCESSFUL AT 25J AND 36J, PATIENT WAS EXTERNALLY RESCUED AGAIN. DEVICE WENT INTO BACK UP MODE. PHYSICIAN ELECTED TO REPLACE BOTH THE LEAD AND THE ICD. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454599 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention CD3249-40, 644171