BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELID II

    MDR report key: 2190682 · Received July 26, 2011

    Report

    Report Number
    1000165971-2011-00261
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVN
    PMA / PMN Number
    P020030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACING LEAD, LOW BIPOLAR PACING IMPEDANCE WAS MEASURED ON A PSA. ANOTHER LEAD WAS SUBSEQUENTLY IMPLANTED INSTEAD. THE PHYSICIAN REPORTED THAT THE SUBJECT LEAD NEEDED TO BE REPOSITIONED DUE TO UNACCEPTABLE ("SMALL SIGNAL") MEASUREMENTS WITH THE PSA. THE LEAD WAS REPOSITIONED SEVERAL TIMES DUE TO UNACCEPTABLE MEASUREMENTS. CONNECTIONS ON THE LEAD CONNECTOR WERE CHECKED AND FOUND TO BE OK. ATRIAL AND VENTRICLE CONNECTIONS WERE REVERSED WHICH REVEALED GOOD RESULTS FOR THE VENTRICULAR LEAD AND UNACCEPTABLE RESULTS FOR THE ATRIAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELID II NVN SORIN CRM STELID II BJF25D 2520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention