BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3903747 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12891
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, HIGH, OUT OF RANGE PACING LEAD IMPEDANCE, HIGH CAPTURE THRESHOLD AND AN INCREASE IN HIGH VOLTAGE LEAD IMPEDANCE WERE OBSERVED. THE PATIENT WAS ASYMPTOMATIC. THE PACING LEAD IMPEDANCE INCREASE WAS GRADUAL OVER THE PREVIOUS YEAR. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380865 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention