BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 1990912 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00794
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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'S HEART BEGINS RACING WHEN BEGINNING TO EXERCISE. WHILE DOING THRESHOLD TESTING THE DEVICE WAS NOTED TO HAVE LOST CAPTURE AND RESET TO EMERGENCY SETTINGS. 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 SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD