BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2811889 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02557
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    April 5, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE DEVICE HYBRID HAD SHORTING WITH LOW RESISTANCE. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE CONFIRMED AND WERE NOTED TO BE DUE TO A DEPLETED BATTERY. THE CAUSE OF THE DEPLETED BATTERY WAS DUE TO EXCESSIVE CURRENT DRAIN. THE CAUSE OF THE EXCESSIVE CURRENT DRAIN WAS CONFIRMED TO BE DUE TO TWO SHORTED TRACES ON THE PERIMETER OF THE DIE STACK.

    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 U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE MEDICAL INSTITUTION AFTER HEARING THE ALERT SOUNDS. DATA FROM THE REMOTE MONITOR REVEALED THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE MEASUREMENTS. THE DEVICE WAS CHECKED AND IT WAS FOUND THERE WAS NO TELEMETRY. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD