BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1854892 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04372
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT VENTRICULAR LEAD IMPEDANCE NOT AVAILABLE DUE TO A MANUAL CLEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WITH LOSS OF CAPTURE. IT WAS NOTED THAT THERE WAS AN INCREASE IN CAPTURE THRESHOLDS AND THAT THE CAPTURE MANAGEMENT FEATURE WAS TESTING TO LOWER VALUES THAN THE CURRENT THRESHOLD. THE DEVICE WAS REPROGRAMMED TO HIGHER THRESHOLDS. THE PHYSICIAN EXPRESSED CONCERN ABOUT USING CAPTURE MANAGEMENT FOR ANY OF HIS PATIENTS. THE DEVICE REMAINS IN USE. NO FURTHER 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 85 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD