BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1072123 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00341
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 23, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS PACING INAPPROPRIATELY. THERE WAS ALSO INCREASING, VARYING IMPEDANCE AND SUBSEQUENT HIGH IMPEDANCE. OVERSENSING WAS ALSO SEEN. WHILE IN FOR A PLANNED PATIENT FOLLOW-UP VISIT, THE INABILITY TO PERFORM THE SENSING TEST WAS ALSO NOTED. THE DEVICE WAS PACING DESPITE VISIBLE INTRINSIC ACTIVITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT SUBCUTANEOUS ANALYSIS. ALL CONNECTIONS AND TESTS WERE NORMAL. HOWEVER, THE PHYSICIAN DECIDED TO USE AN NEW DEVICE. THE DEVICE WAS REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R