BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3133632 · Received May 24, 2013

    Report

    Report Number
    1000165971-2013-00262
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 13, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    THE PHYSICIAN REPORTED THAT FOLLOWING CARDIOVERSION THERAPY ON (B)(6) 2013, OVERSENSING WAS SEEN WITHIN EPISODES STORED BY THE DEVICE IN THE ATRIAL AND VENTRICULAR CHANNELS. REPORTEDLY, THIS OVERSENSING LED TO PACING PAUSES AND ON (B)(6) 2013 AN ABLATION WAS SUCCESSFULLY PERFORMED BECAUSE OF ATRIAL FLUTTERS. IT WAS ALSO REPORTED THAT CARDIOVERSION THERAPY WAS PERFORMED ON (B)(6) 2009, (B)(6) 2010 AND (B)(6) 2012, AND THAT THE PT COLLAPSED TWICE ON (B)(6) 2010. THE SUBJECT DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232246 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2368

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention