BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD 2

    MDR report key: 3864852 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07476
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MPRI
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING, ALONG WITH THE PACING CAPTURE THRESHOLD. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED OVERSENSING INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCREASED THRESHOLDS, INCREASED IMPEDANCE LEVELS AND OVERSENSING WERE EVIDENT ON THE PATIENTS RIGHT VENTRICULAR (RV) LEAD. THE LEAD HAS BEEN CAPPED 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
    338564 CAPSURE VDD 2 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MPRI 5038-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R E2SR01, IMPLANTABLE PULSE GENERATOR (IPG)