BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2831816 · Received November 9, 2012

    Report

    Report Number
    1000165971-2012-00417
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    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) 2012. 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, IT WAS REPORTED THAT COMPLETE LEAD INSERTION INTO THE VENTRICULAR PORT WAS NOT POSSIBLE. PROPER LEAD MEASUREMENT WAS INDICATED PRIOR TO THE CONNECTION ATTEMPT. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO TIGHTEN THE SETSCREW IN ORDER TO CHECK. IF THE PACING PULSES WERE DELIVERED, AND THEY WERE NOT. THE SETSCREW WAS LOOSENED, AND THE TIP OF THE SETSCREW WAS NOT SEEN IN THE PORT, BUT THERE WAS BLOOD AND OTHER FOREIGN MATERIAL IN THE CHANNEL, WHICH THE PHYSICIAN CLEANED. FULL INSERTION OF THE LEAD WAS AGAIN IN NOT POSSIBLE, SO ANOTHER PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY SR 2603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention