BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD

    MDR report key: 2813495 · Received October 31, 2012

    Report

    Report Number
    6000023-2012-00032
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S39
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ATRIAL OVERSENSING. DURING THE LEAD REVISION PROCEDURE THE LEAD WAS MEASURED THROUGH THE ANALYZER AND INDICATED NO ANOMALY. THE LEAD WAS ABANDONED AND THE PHYSICIAN REQUESTED ANALYSIS ON THE IMPLANTABLE PULSE GENERATOR (IPG). A NEW ATRIAL LEAD AND DEVICE WERE IMPLANTED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC, B.V. 5032

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R