BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2914995 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00001
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SORIN C.R.M., 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

    ON (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, DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, CONNECTION PROBLEMS WERE INCURRED IN THE VENTRICULAR CHANNEL. THE PHYSICIAN INDICATED THAT AFTER FULL INSERTION OF THE LEAD AND TIGHTENING OF THE SET-SCREW VENTRICULAR PACING SPIKES COULD NOT BE OBSERVED. FURTHERMORE, THE LEAD COULD BE REMOVED BY PULLING. REPORTEDLY, THE LEAD WAS RECONNECTED AND THE IMPEDANCE MEASURED ON THE LEAD BY THE PACEMAKER WAS >3000 OHMS. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14490 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2632

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention