BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3201690 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00329
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    December 21, 2012
    Report Date
    June 13, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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, THE PT EXPERIENCED SYNCOPE AND FELL DOWN, RESULTING IN BROKEN LEFT FOOT. HE HAD TO STAY IN HOSPITAL FOR 8 DAYS AFTER, BUT NO OPERATION WAS NECESSARY. SINCE THE PT WAS SYMPTOMATIC DURING SENSING TEST, THE PHYSICIAN SUSPECTED THAT SAFER MODE COULD HAVE CONTRIBUTED TO THE PT SYMPTOMS; THE PACING MODE WAS REPROGRAMMED FROM SAFER-R TO DDDR MODE PREVENTING FROM REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296713 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention