BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1792337 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03219
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MODE SWITCH MARKER WAS NOT SEEN IN DEVICE RECORDED DIAGNOSTICS, AND THAT DOUBLE-SENSING OF ATRIAL EVENTS IS OCCURRING: ATRIAL SENSE (AS) MARKERS OCCURRING AFTER ATRIAL REFRACTORY SENSE (AR) MARKERS. THE CALLER ASKED FOR REPROGRAMMING ADVICE. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD