BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 2203521 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01531
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRELIMINARY TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT SYNCOPAL AND INCONTINENT AND WAS RUSHED TO A HOSPITAL. IT WAS ALSO NOTED THAT AT THE HOSPITAL THE PATIENT HAD AN ESCAPE RHYTHM AND THE DEVICE WAS UNABLE TO BE INTERROGATED AND HAD NO OUTPUT. THE PHYSICIAN THOUGHT THE DEVICE REACHED END OF LIFE PREMATURELY. THE DEVICE WAS REMOVED AND REPLACED. 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 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R