BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2121665 · Received June 13, 2011

    Report

    Report Number
    6000144-2011-02104
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    February 21, 2013
    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
    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 ANOTHER EPISODE OF SYNCOPE. A DEVICE CHECK WAS OK AND THE DEVICE REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYNCOPE AND OTHER MEDICAL COMPLICATIONS. THE PATIENT SUSPECTS A POSSIBLE MALFUNCTION OF THE DEVICE. FOLLOW UP INFORMATION WAS OBTAINED AND REVEALED THAT THE DEVICE WAS CHECKED A FEW MONTHS AGO, BUT THE PATIENT HAS NOT BEEN SEEN SINCE THE REOCCURRENCE OF THE SYMPTOMS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other (B)(4) IMPLANTABLE PACING LEAD