BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD-2

    MDR report key: 1990705 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02104
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR IMPEDANCE WAS SUSPECTED TO BE FRACTURED DUE TO HIGH IMPEDANCE AND NO CAPTURE WHEN AT MAXIMUM OUTPUT. THE LEAD WAS 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 46 YR Other ADDRL1 IMPLANTABLE PULSE GENERATOR