BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1925668 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06339
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 12, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS REVEALED THAT NO WERE ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT ATTEMPT, THE DEVICE PACKAGING WAS OPENED AND THE DEVICE WAS NOT USED. ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPILATIONS 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 74 YR Other 1246T COMPETITOR IMPLANTABLE PACING LEAD| 1188T COMPETITOR IMPLANTABLE PACING LEAD