BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 4010479 · Received August 14, 2014

    Report

    Report Number
    2938836-2014-14294
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 23, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, OVERSENSING DUE TO NOISE WAS NOTED. LOW PACING LEAD IMPEDANCE WAS ALSO NOTED. LEAD DAMAGED WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485882 DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7170/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention