BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 D

    MDR report key: 3993554 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01894
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT FEELS SHORTNESS OF BREATH WHEN CLIMBING STAIRS. IT WAS ALSO NOTED BY THE PATIENT THAT THE DEVICE LOWER RATE WAS PROGRAMMED TO 60 BEATS PER MINUTE (BPM) BUT THE PATIENT'S HEART RATE WAS AT 55 BPM. FOLLOW-UP WAS ATTEMPTED TO DETERMINE IF THE DEVICE WAS FUNCTIONING APPROPRIATELY TO CONTOL THE PATIENT'S RATE, OR IF INTERVENTION WAS NECESSARY, BUT NO ADDITIONAL INFORMATION COULD BE OBTAINED. 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
    467758 KAPPA 700 D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND KD701

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR