BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1990207 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00659
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 1, 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
    FL, 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 REPORTED THAT THE DEVICE HAS NOT MADE THE PATIENT FEEL ANY BETTER AND THE PATIENT FEELS LIKE WHEN THE OLD DEVICE NEEDED REPLACING. IT WAS FURTHER REPORTED THAT THE PATIENT HAS HICCUPS, CHEST PAIN AND ISN'T SATISFIED WITH THE DEVICE. FOLLOW UP INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS SEEN AT THE CLINIC BUT THE INFORMATION DID NOT INDICATE THAT ANY INTERVENTION WAS DONE WITH THE DEVICE. THE DEVICE REMAINS IN USE. THERE HAVE BEEN NO PATIENT COMPLICATIONS 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 Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD