BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 14962047 · Received July 8, 2022

    Report

    Report Number
    2017865-2022-14395
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    July 18, 2022
    Report Date
    July 29, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734503167
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G3 MDR-2022-27606-01 WAS LEFT BLANK AND SHOULD HAVE BEEN (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS OVER-SENSING NOISE WHICH LEAD TO PACING INHIBITION. THE PATIENT WAS ASYMPTOMATIC. NO CHANGES WERE MADE AND THERE WERE NO CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THERE WAS A REOCCURRENCE OF OVER-SENSED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS ASYMPTOMATIC. THE RV LEAD WAS CAPPED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2022. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850352 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7121Q/58 3477480 05414734503167

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention FORTIFYASSURA.| TENDRILACTIVE LEAD.