BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST ESCUDO VR

    MDR report key: 1920768 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02149
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. 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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) TESTING CONFIRMED A HIGH CURRENT DRAIN CONDITION. FURTHER ANALYSIS REVEALED IT TO BE GENERATED BY AN INTERNAL CIRCUIT SHORT. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT THE LAST BATTERY VOLTAGE AVAILABLE WAS FROM (B)(6) 2010 AT 3.21 VOLTS.

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) TESTING CONFIRMED A HIGH CURRENT DRAIN CONDITION. FURTHER ANALYSIS REVEALED IT TO BE GENERATED BY AN INTERNAL CIRCUIT SHORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EVENT AND WAS ADMITTED TO THE HOSPITAL. MULTIPLE ATTEMPTS TO INTERROGATE THE PATIENTS DEVICE FAILED AS IT WAS NOT POSSIBLE TO MAINTAIN A TELEMETRY LINK. THE DEVICE WAS REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE WAS RETURNED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EVENT AND WAS ADMITTED TO THE HOSPITAL. MULTIPLE ATTEMPTS TO INTERROGATE THE PATIENTS DEVICE FAILED. TELEMETRY WAS NOT POSSIBLE. THE DEVICE WAS REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST ESCUDO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D144VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R