BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBCUTANEOUS, UNIPOLAR LEAD

    MDR report key: 9668664 · Received February 4, 2020

    Report

    Report Number
    2182208-2020-00226
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 1, 2019
    Report Date
    February 4, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: PHYSIOLOGICAL OPTIMIZATION OF ROBOTIC ENDOSCOPIC EPICARDIAL CRT-D IMPLANTATION USING MULTIELECTRODE ELECTROANATOMIC MAPPING JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2019; 30(11):2564-2568. 10.1111/JCE.14126. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING AN EPICARDIAL DEFIBRILLATION COIL. THE ARTICLE SHOWED THAT AT THE TIME OF FOLLOW UP THE IMPEDANCE OF THE DEFIBRILLATOR COILS WAS "RELATIVELY LOW." A REQUEST FOR ADDITIONAL INFORMATION WAS PERFORMED AND IT WAS LEARNED THAT GIVEN THE SURFACE AREA OF THE COILS LOWER IMPEDANCE VALUES WERE EXPECTED. DEFIBRILLATION TESTING WAS DONE AND FOUND TO BE SUCCESSFUL. THE LEADS REMAIN IN USE AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128570 SUBCUTANEOUS, UNIPOLAR LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6996-58

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR