BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4221047 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17492
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 5, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT FOR HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE. DURING A SUBSEQUENT FOLLOW-UP, NOISE WAS OBSERVED. LEAD WAS CAPPED AND REPLACED. PATIENTS CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702830 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7170Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention