BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3022738 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00149
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 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 AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE, A CONNECTION ISSUE IN THE VENTRICULAR CHANNEL WAS INCURRED. REPORTEDLY, WHEN TIGHTENING THE VENTRICULAR SET-SCREW, CLICKING OF THE ASSOCIATED SCREWDRIVER COULD NOT BE HEARD/FELT, AND PACING SPIKES WERE NOT OBSERVED. THE PHYSICIAN ATTEMPTED AGAIN AFTER LOOSENING THE SET-SCREW, BUT THE ATTEMPT WAS AGAIN UNSUCCESSFUL. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119641 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention