BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE VDD-2

    MDR report key: 2812297 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17425
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    July 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    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 PATIENT'S ATRIAL LEAD HAD A LEAD WARNING FOR LOW IMPEDANCE. THERE WERE MANY LOW IMPEDANCE MEASUREMENTS, AND AN X-RAY DID NOT FIND ANY ANOMALIES. THE LEAD REMAINS IN USE AND WILL BE MONITORED. 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 83 YR Other E2DR01 IMPLANTABLE PULSE GENERATOR