BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 11871471 · Received May 24, 2021

    Report

    Report Number
    2017865-2021-18031
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734503617
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-18033. IT WAS REPORTED THAT A PATIENT PRESENTED ON (B)(6) 2021 FOR A ROUTINE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT'S RIGHT ATRIAL LEAD COULD NOT BE REMOVED, AND THAT THERE WAS A BLACK COLOR ON THE METAL OF THE PIN CONNECTOR AS WELL AS A YELLOW DISCOLORED HEADER ON THE PATIENT'S PACEMAKER. THE RIGHT ATRIAL LEAD UNRAVELED WHILE ATTEMPTING TO REMOVE THE LEAD, SO THE PHYSICIAN ELECTED TO CAP THE LEAD. THE PHYSICIAN ALSO BROKE OFF THE HEADER OF THE DEVICE WHILE ATTEMPTING TO REMOVE THE CONNECTOR. THE PACEMAKER WAS EXPLANTED AND REPLACED WITHOUT FURTHER CONSEQUENCE, AND A NEW ATRIAL LEAD WAS NOT PLACED. THE PATIENT WAS DISCHARGED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766372 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 3649501 05414734503617

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR TENDRIL SDX LEAD.