BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1841213 · Received September 10, 2010

    Report

    Report Number
    1000165971-2010-00892
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 27, 2010
    Manufacturer
    SORIN BIOMEDICA CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTED THAT AT A SCHEDULED FOLLOW-UP, THE RV CONTINUITY WAS DISPLAYED AS OPEN, WHEN THE ASSOCIATED OVATIO DR, (B)(4) WAS INTERROGATED. A REVISION WAS SCHEDULED FOR (B)(6)2010 TO CORRECT THE PROBLEM. IT WAS ALSO REPORTED THAT THE RV CONTINUITY WAS AT AN ELEVATED VALUE DURING THE FOLLOW-UP PERFORMED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN BIOMEDICA CRM ISOLINE 2CT6 2295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention