BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 2812489 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02536
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A TANTALUM CAPACITOR.

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE US.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT DURING THE ANALYSIS OF THE RETURNED DEVICE THE HYBRID WAS DAMAGED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT. THE ANALYST NOTED THE CURRENT DRAIN IS ABOVE NOMINAL. THE BATTERY DID NOT REACH ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE ESTIMATED REMAINING LONGEVITY IS APPROXIMATELY 12 MONTHS. THE ESTIMATED LONGEVITY IS SHORT OF EXPECTATIONS, UNRELATED TO KNOWN ESTIMATOR ISSUE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: INITIALLY THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE SAVE TO DISK ANALYSIS RESULTS FOUND THAT THE DEVICE WAS REAPPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ESTIMATED LONGEVITY OF THE DEVICE WAS SHORTER THAN ONE YEAR WITH NORMAL ELECTRICAL PARAMETERS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSURA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC S.A. EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R