BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3201658 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00323
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP RELATIVE TO THE SUBJECT LEAD, SEVERAL EPISODES OF NOISE WERE STORED WITHIN THE ICD MEMORY. PROVOCATIVE MANEUVERS COULD NOT RECREATE THE NOISE EPISODES. ALL OTHER TESTS WERE NORMAL; RV LEAD IMPEDANCE 563 OHMS AND CONTINUITY WAS NORMAL. A REINTERVENTION WAS PERFORMED TO REPLACE THE ICD (OVATIO VER-SN (B)(4)) AND LEAD. THE LEAD REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295722 ISOLINE MRM SORIN GROUP ITALIA SRL ISOLINE 2CR6 2384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention