BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE VDD-2

    MDR report key: 1991933 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02639
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    October 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD FAILED TO SENSE ANY ACTIVITY IN THE RIGHT ATRIUM DESPITE TRYING SEVERAL DIFFERENT POSITIONS. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD-2 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5038 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other