BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 1924590 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00860
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE APPEARED TO BE OVERSENSING THE P-WAVE. SETTINGS WERE ADJUSTED AND PATIENT WAS MONITORED. NO MORE OVERSENSING OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE APPEARED TO BE OVERSENSING THE P-WAVE. SETTINGS WERE ADJUSTED AND PATIENT WAS MONITORED. NO MORE OVERSENSING OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT .IT WAS FURTHER REPORTED THAT THE LEAD CONTINUES TO OVERSENSE AND THE PATIENT WAS RECEIVING EXTRA PACING AT TIMES. THE PATIENT REPORTED THAT THEY FELT "DIZZY" AT TIMES. THE SETTINGS WERE REPROGRAMMED ONCE AGAIN AND THE LEAD 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
    1 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR903 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 5592 IMPLANTABLE PACING LEAD| 5592 IMPLANTABLE PACING LEAD