BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNET, TEST, PACEMAKER

    MDR report key: 8498655 · Received April 10, 2019

    Report

    Report Number
    2182208-2019-00674
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 10, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS SLITTING THE CATHETER AND THE SLITTER SLIPPED OFF. IT WAS ALSO REPORTED THE PHYSICIAN HAD DIFFICULTY AFFIXING TO START SLITTING AGAIN AND THIS PROCESS THE RIGHT VENTRICULAR (RV) LEAD INSULATION WAS DAMAGED. IT WAS NOTED THE LEAD NUMBERS WERE STABLE DESPITE THE INSULATION BREACH. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294174 MAGNET, TEST, PACEMAKER DTG MEDTRONIC, INC. MDT-SLITTER

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR