BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR POLYURETHANE LEAD

    MDR report key: 9629105 · Received January 24, 2020

    Report

    Report Number
    2017865-2020-00954
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 17, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE SEP 23, 2014. THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. 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

    ADDITIONAL INFORMATION: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    MANUFACTURER REPORT NUMBER: 2017865-2019-17554, MANUFACTURER REPORT NUMBER: 2017865-2020-00952, MANUFACTURER REPORT NUMBER: 2017865-2020-00953. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE CAUSE OF THE INFECTION WAS NOT KNOWN. ALSO, THE RIGHT ATRIAL LEAD HAD ERODED THROUGH THE SKIN ON THE PATIENT¿S CHEST. THE PACEMAKER, RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD, AND PREVIOUSLY CAPPED RIGHT VENTRICULAR LEAD WERE EXPLANTED ON (B)(6) 2020. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89367 BIPOLAR POLYURETHANE LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1038T/58

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention