BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1770911 · Received July 27, 2010

    Report

    Report Number
    6000094-2010-01427
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 25, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY (B)(4) THE DEVICE WAS RETURNED TO THE LAB DUE TO ERI AND CONNECTOR PROBLEM AND INCREASING LEAD IMPEDANCES. PRELIMINARY ANALYSIS REVEALED THE DEVICE AT ERI WITH A BATTERY VOLTAGE OF 2.41 VOLTS. FURTHER TESTING SHOWED THE DEVICE WAS AT NORMAL ERI (B)(6)2008. THE VENTRICULAR RING AND TIP, ATRIAL RING AND CASE FRACTURES, ON THE FEEDTHROUGH TO SETSCREW BLOCK WERE THE RESULT OF FATIGUE. THE ATRIAL RING FEEDTHROUGH WAS A SINGLE CYCLE FRACTURE. THE EXACT TIME OF THE FRACTURES COULD NOT BE DETERMINED DUE TO DATA BEING TERMINATED DUE TO ERI.

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACEMAKER WAS BEING REPLACED FOR ELECTIVE REPLACEMENT INDICATOR, THE PACEMAKER HEAD WAS DISCONNECTED FROM THE PACEMAKER BODY WHEN THEY REMOVED IT FROM THE PATIENT. THE PACEMAKER WAS IMPLANTED SUBMUSCULARLY IN A YOUNG PATIENT. IT WAS ALSO REPORTED THAT FOR MANY MONTHS THE LEAD IMPEDANCES HAVE INCREASED. THE DEVICE AND VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACEMAKER WAS BEING REPLACED (FOR ERI), THE PACEMAKER HEAD WAS DISCONNECTED FROM THE PACEMAKER BODY WHEN THEY REMOVED IT FROM THE PATIENT. THE PACEMAKER WAS IMPLANTED SUB MUSCULARLY IN A YOUNG PATIENT. IT WAS ALSO REPORTED THAT FOR MANY MONTHS, THE LEAD IMPEDANCES (ATRIAL AND VENTRICULAR) HAVE INCREASED. THE DEVICE AND VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW UP REVEALED THE DOCTOR NOTES INDICATE "THE PACER DYSFUNCTION MAY BE ATTRIBUTED TO THE GROWTH OF THE CHILD AS THE DEVICE WAS IN THE CHILD FOR 10 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KDR733 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention