BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3201665 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00324
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SORIN GROUP ITALIA, S.R.L.
    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

    WITHIN THE MEMORY OF THE ASSOCIATED ICD (OVATIO VR - SN (B)(4)) OVERSENSING RELATIVE TO THE SUBJECT LEAD WAS IDENTIFIED IN ONE STORED EPISODE ON (B)(6) 2013. LEAD REPLACEMENT IS YET TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296780 ISOLINE MRM SORIN GROUP ITALIA, S.R.L. ISOLINE 2CR6 2222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention