BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

    MDR report key: 17765851 · Received September 15, 2023

    Report

    Report Number
    MW5145747
    Event Type
    Injury
    Date Received
    September 15, 2023
    Report Date
    September 1, 2023
    Manufacturer
    SORIN BIOMEDICAL, INC./SORIN CRM SAS
    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 THE LEAD WAS CAPPED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE 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
    84337 DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN BIOMEDICAL, INC./SORIN CRM SAS 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown