BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1854735 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04431
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IT WAS REPORTED THAT THE PATIENT FELT THE DEVICE WAS NOT PACING CORRECTLY. 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 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other 4076-52 IMPLANTABLE PACING LEAD| 4076-58 IMPLANTABLE PACING LEAD