BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2190995 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00271
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. OTHER: THE PROGRAMMER FILES WERE REVIEWED. (B)(4). CONCLUSION: A RE-INTERVENTION SHOULD BE EVALUATED BY THE PHYSICIAN IN ORDER TO CHECK PROPER OPERATION OF THE LEAD (VISUAL CHECK, ELECTRICAL TESTS / SENSING TESTS LEAD DISCONNECTED) AND PROPER CONNECTION OF THE LEAD. THE DEVICE OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2011 FOLLOW-UP THE PHYSICIAN OBSERVED THAT: NO VENTRICULAR SPIKES WERE OBSERVED ON THE ECG BOTH IN THE PROGRAMMED SETTINGS AND UPON MAGNET APPLICATION. UPON DEVICE INTERROGATION HIGH VENTRICULAR IMPEDANCE WAS NOTICED. THE VENTRICULAR LEAD IMPEDANCE WAS MEASURED AT 714 OHMS IN BIPOLAR CONFIGURATION AND 589 OHMS IN UNIPOLAR CONFIGURATION. NOISE EPISODES WERE RECORDED IN THE DEVICE MEMORY. RADIOLOGIC EVALUATION PERFORMED ON IMPLANT DAY DID NOT REVEAL CONNECTION AND/OR LEAD ISSUE. THE PATIENT EXPERIENCED AN IMPACT ON THE CHEST CLOSE TO THE PACEMAKER POCKET AT BEGINNING OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention