BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1791806 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01435
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    February 17, 2009
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS REVEALED THAT THE REPORTED ATRIAL UNDERSENSING WAS THE RESULT OF A LEAKY CERAMIC CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE ATRIAL LEAD AND T-WAVE PACING ON VENTRICULAR. THE DEVICE WAS REPLACED AND THE LEADS REMAIN IMPLANTED. 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 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5024 IMPLANTABLE PACING LEAD