BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 9644638 · Received January 29, 2020

    Report

    Report Number
    2938836-2020-00502
    Event Type
    Death
    Date Received
    January 29, 2020
    Date of Event
    January 13, 2020
    Report Date
    April 10, 2020
    Manufacturer
    ABBOTT
    Product Code
    NVY
    UDI-DI
    05414734502818
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    FURTHER INFORMATION INDICATED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH AND THEREFORE SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR).

    Description of Event or Problem · 1

    DURING AN IN-CLINIC FOLLOW-UP, A VARIATION ON R-WAVE SENSING AND AN INCREASE IN CAPTURE THRESHOLD WAS NOTED ON THE DEVICE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. LATER AT HOME, THE PATIENT EXPIRED DUE TO CARDIAC ARREST. TECHNICAL SERVICES REVIEWED THE DEVICE SESSION RECORDS AND NOTED VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) EPISODES, WHICH WERE OVER-WRITTEN BY SEVERAL EPISODES OF NONSUSTAINED OVERSENSING. THERE WERE THREE ABORTED HIGH VOLTAGE SHOCKS DUE TO UNDERSENSING. THE PHYSICIAN INDICATED THERE WAS NO ALLEGATION THAT THE PATIENT'S DEATH WAS RELATED TO A MALFUNCTION OF THE LEAD OR DEVICE. FURTHERMORE, TECHNICAL SERVICES SUGGESTED THE PATIENT HAD AN AGONAL RHYTHM WHICH WOULD HAVE BEEN NATURALLY UNDERSENSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105737 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ABBOTT 7120Q/58 3228341 05414734502818

    Patients

    Seq Age Sex Outcome Treatment
    1 Death