BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 7392520 · Received April 3, 2018

    Report

    Report Number
    2017865-2018-04983
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    March 9, 2018
    Report Date
    September 3, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF NOISE WAS CONFIRMED. ONLY THE DISTAL PORTION OF THE LEAD WAS RETURNED IN ONE PIECE. ANALYSIS FOUND AN EXTERNAL INSULATION ABRASION CONSISTENT WITH FRICTION TO THE DEVICE CAN BREACHING THE RING ELECTRODE CABLES LUMEN AT 44.4 CM TO 45.0 CM FROM THE DISTAL TIP. ONE OF THE RING ELECTRODE CABLES WAS FOUND TO BE ABRADED THROUGH. THE PTFE LINER WAS FOUND TO BE NORMAL IN THIS REGION. THE CAUSE OF THE REPORTED EVENT WAS ISOLATED TO THE EXPOSED RING ELECTRODE CABLE AT THE ABRASION ZONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD BEEN PROGRAMMED TO VVI ¿ 40 PPM AND THE DEFIBRILLATION THERAPY HAD BEEN TURNED OFF FOR SOME YEARS AS THE PATIENT¿S EJECTION FRACTION ¿ EF HAD IMPROVED. NOW THE PATIENT¿S EF HAD DECREASED AND WHEN THE PHYSICIAN WAS PROGRAMMING THE DEVICE; IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD WAS EXHIBITED OVERSENSING OF NOISE. THE PATIENT WAS ASYMPTOMATIC TO THE EVENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2018. THE PATIENT WAS IN STABLE CONDITION PRIOR, DURING AND POST PROCEDURE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTED THAT THE CHRONIC CAPPED LEAD WAS EXPLANTED ON (B)(6) 2020. AN ELECTIVE DECISION WAS MADE BY THE PHYSICIAN TO REMOVE EXCESS HARDWARE IN THE PATIENT DUE TO OTHER ONGOING HEALTH ISSUES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235262 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7120Q/65 3656714

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention