BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD-2

    MDR report key: 2812430 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16189
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    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 THERE WAS A RISE IN IMPEDANCE ON THE LEAD SINCE IMPLANT. ONE MONTH POST IMPLANT, THE DEVICE OUTPUT WAS INCREASED, HOWEVER PACING FAILURE WAS OBSERVED TEN DAYS LATER. THE CAUSE OF THE THRESHOLD INCREASE WAS DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED WITH AN ACTIVE FIXATION LEAD. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR