BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2792260 · Received October 12, 2012

    Report

    Report Number
    1000165971-2012-00387
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SORING CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, AT ONE-WEEK POST IMPLANT CHECK (ON (B)(6) 2012) HIGH VENTRICULAR LEAD IMPEDANCE (>3000 OHMS) WAS CONFIRMED. THEREFORE, OUTPUT WAS REPROGRAMMED TO 7.5V/1MS (UNIPOLAR). RE-INTERVENTION WAS SCHEDULED FOR (B)(6) 2012. HOWEVER, IT WAS POSTPONED BECAUSE DEVICE WAS CHECKED BEFORE RE-INTERVENTION AND BOTH VENTRICULAR LEAD IMPEDANCE AND THRESHOLD WERE FOUND WITHIN NORMAL RANGES. CONSEQUENTLY, OUTPUT WAS RE-PROGRAMMED TO 5V/1MS AND ANOTHER CHECK WILL BE PERFORMED WITHIN TWO WEEKS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORING CRM S.R.L. REPLY DR 2609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention