BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC LEAD

    MDR report key: 8010837 · Received October 26, 2018

    Report

    Report Number
    2182208-2018-01964
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    June 14, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. POSSIBLE MODELS COULD INCLUDE: 4968, 5071, 4951, 5076, 4194. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LONGITUDINAL OUTCOMES OF EPICARDIAL AND ENDOCARDIAL PACEMAKER LEADS IN THE ADULT FONTAN PATIENT. PEDIATRIC CARDIOLOGY. 2018; 39(7):1476-1483. 10.1007/S00246-018-1919-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING EPICARDIAL AND ENDOCARDIAL PACEMAKER LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE MEAN FOLLOW-UP TIME FOR THE STUDY WAS 7.7 YEARS. THE ARTICLE REPORTS VENTRICULAR EPICARDIAL LEADS WERE ASSOCIATED WITH TEMPORAL DECREASE IN IMPEDANCE AND INCREASE IN THRESHOLDS. EPICARDIAL LEADS ALSO WERE NOTED TO HAVE A HIGHER RATE OF "FAILURE". THE STATUS OF THE LEADS IN UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849413 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR