BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA

    MDR report key: 2953570 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01999
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THE DEVICE. IT WAS NOTED THAT PREVIOUS ATTEMPTS WITH A SECOND PROGRAMMER WERE ALSO UNSUCCESSFUL. MAGNET RESPONSE WAS SEEN. 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
    57482 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR 5076 IMPLANTABLE PACING LEAD