BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2811278 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02378
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY FOR: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED AND THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. PERFORMANCE DATA REVEALED THAT ALERTS FOR THE RIGHT VENTRICULAR LEAD TRIGGERED AND THERE WAS NON-PHYSIOLOGIC OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED AND THERE WAS NOISE OBSERVED ON THE REMOTE MONITORING TRANSMISSION. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING. THE PHYSICIAN PERFORMED AN X-RAY TO IDENTIFY IF THERE WERE ADDITIONAL ISSUES. THE PHYSICIAN DECIDED TO REPLACE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. 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 VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R