BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2790947 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02107
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 27, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER 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 72 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD