BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 4163356 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02987
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT PRODUCT: PRODUCT ID 2067, RADIOFREQUENCY PROGRAMMER HEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PROGRAMMER WAS INTERROGATING A PACEMAKER, THE PACEMAKER WENT INTO EMERGENCY PACING MODE. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD DID NOT WORK. THE PROGRAMMER AND THE RADIOFREQUENCY PROGRAMMER HEAD WERE RETURNED FOR SERVICE. FOLLOW-UP WAS CONDUCTED BUT THE INFORMATION FOR THE PACEMAKER WERE NOT AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644842 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2090AM PROGRAMMER