BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1936294 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01018
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., 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)(4) - THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS MDR WAS IMPLANTED ON (B)(6) 2010. ON (B)(6) 2010, A PACING FAILURE EPISODE AND AN INCREASE OF THE ATRIAL AUTOTHRESHOLD WERE OBSERVED. THUS A REOPERATION WAS SCHEDULED ON (B)(6) 2010 TO REPOSITION THE ATRIAL LEAD. HOWEVER, DURING THE REINTERVENTION, THE PHYSICIAN OBSERVED A VENTRICULAR PACING RATE BETWEEN 70-120 MIN-1. AFTER THE REOPERATION, NO OTHER ANOMALY WAS NOTED BY THE PHYSICIAN. HE REQUESTED EXPLANATIONS ABOUT THE OBSERVED PACING RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention