BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2791434 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02204
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 9, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. IMPLANT DETECT WAS NEVER COMPLETED.

    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 DURING FOLLOWUP A MONTH AFTER IMPLANT IT WAS NOTED THAT NO HISTORY WAS AVAILABLE AND IMPLANT DETECT WAS STILL INITIALIZING. IT WAS NOTED THAT THE DEVICE WAS AT VVIR. THE DEVICE WAS REPROGRAMMED AND 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
    1 CONSULTA CRT-P IMPLANTABLE PULSE GENERATOR OJX MEDTRONIC S.A. C3TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 4296 IMPLANTABLE PACING LEAD| 1388T COMPETITOR IMPLANTABLE PACING LEAD| 1452T COMPETITOR IMPLANTABLE PACING LEAD