BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2230684 · Received August 12, 2011

    Report

    Report Number
    1000165971-2011-00305
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 29, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A POSITIONING ATTEMPT OF THE SUBJECT LEAD, COMPLETE STYLET INSERTION WITHIN THE LEAD LUMEN WAS VERY DIFFICULT DUE TO GREAT RESISTANCE. ONCE THE STYLET WAS COMPLETELY INSIDE THE LEAD, THE LEAD TIP WAS KINKED (REPORTEDLY, NO SIGNIFICANT ANGLE FORMED BY THE LEAD PRIOR TO STYLET INSERTION WAS NOTICED). THE PHYSICIAN INDICATED THAT THIS HAPPENED WITH SEVERAL DIFFERENT STYLETS. THE SUBJECT LEAD WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention