BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 2955479 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00284
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL PORT WAS PLUGGED IN THE DEVICE AT IMPLANT AS THE PATIENT IS IN ATRIAL FIBRILLATION. AFTER REVIEW OFTHE DEVICE DATA, IT WAS NOTED THERE WAS ATRIAL OVERSENSING DUE TO CROSS-CHAMBER SENSING FROM VENTRICULAR PACING. ADJUSTING THE ATRIAL SENSITIVITY WAS RECOMMENDED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59321 PROTECTA CRT-D NIK IPG MFG SWITZERLAND D364TRM

    Patients

    Seq Age Sex Outcome Treatment
    1