BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2810892 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02373
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEART ALERT TONES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. THE PHYSICIAN SUSPECTED A SETSCREW ISSUE, HOWEVER, ALL SCANS WERE CLEAR AND CLEAN AND THE CHEST X-RAY WAS NORMAL WITH NO SIGNS OF FRACTURE AND THE LEADS WERE SEATED PROPERLY. UPON RECEIVING CONTINUED MEASUREMENTS OF HIGH IMPEDANCE ON THE RV LEAD, THE PHYSICIAN OPENED THE POCKET AND DISCOVERED THAT THERE WAS A LOOSE SETSCREW. THE SETSCREW WAS TIGHTENED AND THE DEVICE AND THE RV LEAD REMAIN 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
    1 PROTECTA XT CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D354TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R