BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 2811970 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02339
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. PERFORMANCE DATA WAS RECEIVED AND ANALYZED. THE SAVE TO DISK PRIMARY FINDING NOTED NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WORRIES WHETHER THE DEVICE WORKS PROPERLY BECAUSE IT DOES NOT TURN "END OF LIFE" IN SPITE OF THE SUDDEN DROP IN BATTERY VOLTAGE. IT WAS NOTED THAT THERE IS A BATTERY MEASURING ISSUE WITH THE DEVICE. INITIALLY, THE DEVICE REMAINED IN USE AS THE PHYSICIAN DID NOT BELIEVE THAT IMMEDIATE ACTION IS NECESSARY. IT WAS LATER REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS AND WAS REPLACED WITH A NEW ONE. 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 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. KDR921

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R 5554 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD