BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1992020 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00971
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 28, 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
    OH, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT CALLED TO REPORT THAT THEY HAD BLOOD TRICKLE AT THE SITE OF THE IMPLANT. THE DEVICE REMAINS IN USE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other (B)(4) IMPLANTABLE PACING LEAD