BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3133644 · Received May 24, 2013

    Report

    Report Number
    1000165971-2013-00274
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 17, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. 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 SINCE (B)(6) 2013, EPISODES STORED WITHIN THE MEMORY OF THE ASSOCIATED ICD SHOW MANY SIGNS OF NOISE RELATIVE TO THE SUBJECT LEAD. A RE-INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE, BUT THE SUBJECT LEAD COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232261 ISOLINE MRM SORIN GROUP ITALIA SRL ISOLINE 2CR6 2277

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention