BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE 2CR AND ISOLINE 2CT LEADS

    MDR report key: 17977227 · Received October 19, 2023

    Report

    Report Number
    MW5147195
    Event Type
    Injury
    Date Received
    October 19, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MICROPORT CRM USA INC.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A NON PRODUCT EXPERIENCE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579140 ISOLINE 2CR AND ISOLINE 2CT LEADS DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM MICROPORT CRM USA INC. 5BPB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown