BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3884813 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12093
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    May 16, 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 Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE HOSPITAL, UNDERSENSING OF FINE VENTRICULAR FIBRILLATION WAS OBSERVED. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. THE DEVICE SENSITIVITY WAS PROGRAMMED TO MAXIMUM SETTINGS, BUT UNDERSENSING WAS STILL NOTED. IT WAS LATER REPORTED THAT THE LEAD HAD DISLODGED. IT WAS DETERMINED THAT THE PATIENT HAD TWIDDLERS SYNDROME. AN INCREASE IN IMPEDANCE AND A DECREASE IN R-WAVE AMPLITUDE WERE NOTED. THE DECISION WAS MADE TO NOT INTERVENE FURTHER AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359992 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death