BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781910 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09984
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NUMBER OF VF EPISODES WERE DETECTED DUE TO NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE NOISE WAS DETERMINED TO BE MYOPOTENTIAL OVERSENSING ON THE ICD. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED VERY SMALL R-WAVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259363 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention