BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2992310 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00096
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SORIN CRM S.R.I.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: (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

    ON (B)(6) 2013, A NEW VENTRICULAR LEAD WAS CONNECTED TO THE SUBJECT DEVICE. THE DEVICE WAS ALREADY IMPLANTED BUT GOT MOVED TO THE LEFT SIDE OF THE PATIENT. OLD ATRIAL AND VENTRICULAR LEADS (AT RIGHT SIDE) WERE ISOLATED, BUT NOT EXTRACTED. ON (B)(6), THE NEW LEAD HAD TO BE RE-POSITIONED. ON (B)(6), THE DEVICE WAS FOUND IN STANDBY MODE. REPORTEDLY, DURING PARAMETERS REPROGRAMMING AFTER RE-INITIALIZATION, A PAUSE OF ROUGHLY 5 SECONDS WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89309 REPLY NVZ SORIN CRM S.R.I. REPLY DR 2469

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention