BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 2791379 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05527
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 4, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 ANALYSIS FOUND NO ANOMALIES. VISUAL ANALYSIS NOTED THAT THE PATIENT INFORMATION WAS PROGRAMMED ON 04-AUGUST-2012 AT 2:22PM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE USED, HOWEVER, THE SERIAL NUMBER WAS "ZEROED OUT" AND WHEN PARAMETERS WERE ATTEMPTED TO BE REPROGRAMMED THE PROGRAM BUTTON WAS "GRAYED OUT" AND NO LOCKOUT DISPLAYED. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other