BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3022730 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00156
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING A REGULAR PACEMAKER CHECK, IT WAS REPORTEDLY NOTICED THAT THE VENTRICULAR LEAD IMPEDANCE WAS ABOVE 3000 OHMS, ASSOCIATED WITH V PACING FAILURE (NON-SORIN LEAD). WHEN SOME PRESSURE WAS APPLIED AROUND THE DEVICE AND LEAD AREA, NORMAL V LEAD MEASUREMENTS WERE OBTAINED, BUT INTERMITTENT V PACING FAILURE WAS STILL OBSERVED. A RE-INTERVENTION WILL BE PERFORMED SHORTLY. AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120633 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention