BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2964848 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02286
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, OPERATIONS CO., JUNCOS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT THEY HAD THEIR DEVICE ADJUSTED ABOUT 1 1/2 WEEKS AGO AND SINCE THEN, THE PATIENT GETS SHORT OF BREATH (SOB) WHEN WALKING A SHORT DISTANCE OR GOING UPSTAIRS.THE PATIENT WAS INQUIRING IF THIS COULD BE RELATED TO THE "DEVICE ADJUSTMENT". THE PATIENT ALSO REPORTED THAT THEY ARE "HUFFING <(>&<)> PUFFING". THE PATIENT WAS REFERRED TO CONTACT THEIR PHYSICIAN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67808 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO, OPERATIONS CO., JUNCOS ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention 1346T COMPETITOR NON-DEFIB LEAD