BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELA

    MDR report key: 3012440 · Received March 15, 2013

    Report

    Report Number
    9610579-2013-00026
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVN
    PMA / PMN Number
    P020030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    HIGH LEAD IMPEDANCE (>3000OHMS WITH BIPOLAR SETTING) AND LOW LEAD IMPEDANCE (UNDER 200OHMS WITH UNIPOLAR SETTING) WERE REPORTED IN RELATION TO THE SUBJECT LEAD. LEAD DAMAGE AROUND SUBCLAVICULAR AREA WAS INDICATED VIA X-RAY. A RE-INTERVENTION WAS PERFORMED TO REPLACED THE LEAD, WHICH WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110286 STELA NVN SORIN CRM T84F

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention