BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 2200602 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-00995
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION THAT MEETS EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO QUESTION DEVICE FUNCTION AT ELECTIVE REPLACEMENT INDICATOR (ERI); THE PATIENT REPORTED FEELING SHORTNESS OF BREATH (SOB) AND DIZZINESS OCCASIONALLY AND ALSO QUESTIONED PROGRAMMING OF RATE RESPONSE (RR) AFTER IMPLANT. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WENT TO ERI AND THE PATIENT BECAME SYMPTOMATIC WITH PACEMAKER SYNDROME AS A RESULT. THE IPG WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS