BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2964472 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02275
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT CONTINUED: 407452 IMPLANTABLE PACING LEAD: (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SHORTNESS OF BREATH WITH DAILY ACTIVITIES. HISTOGRAMS SHOWED THE PATIENT'S HEART RATE WAS MOSTLY IN THE 50-60 BPM. A CHANGE IN RATE RESPONSE WAS RECOMMENDED. THE PATIENT WILL BE BROUGHT INTO THE OFFICE TO TEST FOR CHANGES. 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
    67917 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SDR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 457445 IMPLANTABLE PACING LEAD