BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1874672 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05407
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 26, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY COULD NOT INTERROGATE THE PACEMAKER AND RECEIVED ERROR MESSAGES AND DID NOT RESPOND TO MAGNET. PATIENT WAS REPORTED TO HAVE RECENTLY FALLEN. ANOTHER PROGRAMMER WAS USED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD