BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 9147696 · Received October 2, 2019

    Report

    Report Number
    2017865-2019-14527
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501743
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE PIN MEASURING 8.5 CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 4.5 - 4.7 CM FROM THE PIN DUE TO DEGRADATION.

    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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 201786-2019-14530. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATING ROOM FOR LEAD REVISION. THE PATIENT'S RIGHT VENTRICULAR LEAD HAD A HISTORY OF NOISE AND WAS BEING REPLACED. DURING PROCEDURE, THE PHYSICIAN NOTICED AN INSULATION BREACH ON THE RIGHT ATRIAL LEAD. THE LEADS WERE CAPPED ON 18 SEPTEMBER 2019 AND A PORTION OF THE LEAD WAS EXPLANTED. ONLY THE RIGHT VENTRICULAR LEAD WAS REPLACED. PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941242 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/46 2829934 05414734501743

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR