BEUDAMED
    FDA Adverse Event Summary report: N

    RUBY 3

    MDR report key: 1863352 · Received October 9, 2010

    Report

    Report Number
    6000094-2010-02027
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 ERI (ELECTIVE REPLACEMENT INDICATOR) WAS THE RESULT OF NORMAL BATTERY DEPLETION. THE MEMORY ERROR WAS POSSIBLY THE RESULT OF AN ENVIRONMENTAL CONDITION AND COULD HAVE BEEN RESET WITHOUT EXPLANTING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTED PACEMAKER, WHEN INTERROGATED, GAVE THE MESSAGE "PACEMAKER MEMORY CORRUPTED". THE PACEMAKER WAS WORKING AS NORMAL. THE DEVICE WAS LATER EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUBY 3 ASKU DXY MEDTRONIC S.A. 740 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD