BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3012562 · Received March 15, 2013

    Report

    Report Number
    1000165971-2013-00142
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    May 7, 2008
    Report Date
    March 1, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN IN THIS CASE REPORTED EROSION OF THE POCKET BY THE ICD WITH ASSOCIATED INFECTION. THE ASSOCIATED ICD IS AN OVATIO WITH SERIAL NUMBER (B)(4). DUE TO THE INFECTION, THE ICD SYSTEM WAS REPLACED AND IMPLANTED ON THE OPPOSITE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110996 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention