BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2182208-2018-00559

    MDR report key: 7417668 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00559
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    June 1, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED AN R-WAVE AMPLITUDE MEASUREMENT ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A DECREASE IN THE R-WAVE AMPLITUDE AND IT VARIED. RE-PROGRAMMING WAS PERFORMED. APPROXIMATELY THREE MONTHS LATER, THE LEAD DISPLAYED ONE HIGH RATE NON-SUSTAINED VENTRICULAR FIBRILLATION EPISODE, SHORT V-V TIMES, OVER-SENSING, AND LOW R WAVES. IT WAS DETERMINED RE-PROGRAMMING WOULD BE PERFORMED BY "PUSHING THE DETECTION INTERVALS OUT, PROVOCATION TESTS DONE, AND AN INCREASE IN REMOTE MONITORING. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253926 DTB MEDTRONIC, PLC UNK-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention