BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 9445402 · Received December 10, 2019

    Report

    Report Number
    2017865-2019-17698
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 22, 2019
    Report Date
    February 24, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734503174
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    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

    X-RAY WAS MISSPELLED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED NO CAPTURE AND A DROP OF R-WAVE VALUES. THE PATIENT ALSO COMPLAINED OF AN ODD SENSATION DURING PACING. WHEN THE LEAD WAS TURNED OFF, THE SENSATION WENT AWAY. THE PHYSICIAN BELIEVED THE LEAD HAD PERFORATED AFTER LOOKING AT THE X-RAY. ECHOCARDIOGRAM SHOWED NO FLUID BUILD UP. THE LEAD WAS EXPLANTED AND REPLACED. ASIDE FROM THE PACING SENSATION, THE PATIENT DESCRIBED NO PAIN OR DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241800 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q/58 A000083374 05414734503174

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention