BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3254024 · Received July 26, 2013

    Report

    Report Number
    1000165971-2013-00369
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 17, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    REPORTEDLY, A REINTERVENTION WAS PERFORMED TWO DAYS AFTER IMPLANTATION DUE TO INTERMITTENT CAPTURE FAILURE. PHYSICIAN SUSPECTED RIGHT VENTRICULAR LEAD DISLODGEMENT. DURING REINTERVENTION, INTERMITTENT CAPTURE WAS OBSERVED AGAIN, BUT THE LEAD POSITION CHECKED BY FLUOROSCOPY WAS REPORTEDLY GOOD. THE PACEMAKER WAS DISCONNECTED FROM THE LEAD AND PACING WAS DELIVERED VIA THE ANALYZER. A THRESHOLD TEST WAS PERFORMED THAT DID NOT REVEAL ANY LOSS OF CAPTURE. ACCORDING TO THE PHYSICIAN, NO LEAD REPOSITIONING WAS NECESSARY. A PACEMAKER ISSUE WAS RATHER SUSPECTED. THEREFORE, IT WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351516 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY SR 2700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention