BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3022729 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00162
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, THE PT WAS ADMITTED TO THE HOSPITAL DUE TO A LOW HEART RATE OF 34 BPM. INTERROGATION OF THE SUBJECT DEVICE REVEALED A HIGH VENTRICULAR PACING IMPEDANCE (ABOVE 3000 OHMS). A RE-INTERVENTION WAS PERFORMED AND THE LEAD COULD BE MOVED IN THE HEADER WHEN MANIPULATED. PSA TESTING OF THE LEAD REVEALED NORMAL VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119460 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention