BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2123091 · Received September 5, 2008

    Report

    Report Number
    1000165971-2008-00002
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 5, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SORIN BIOMEDICA CRM
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2008. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE LEAD INVOLVED IN THIS MDR REPORT WAS EXPLANTED 22 MONTHS AFTER IMPLANT BECAUSE OF A LOW IMPEDANCE. MEMORY DATA FROM THE ICD WHICH WAS CONNECTED TO THIS LEAD SHOWED THAT: NUMEROUS NOISY EPISODES WERE RECORDED; 59 SHOCKS WERE DELIVERED SINCE THE IMPLANTATION ACCORDING TO STATISTIC COUNTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM - IMPLANTABLE DEFIBRILLATION LEAD MRM SORIN BIOMEDICA CRM 2CR6 2142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention