BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3990435 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08656
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    December 19, 2013
    Report Date
    June 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE 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 ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED RANGE. VENTRICULAR LEAD WARNING RECORDED ON (B)(6) 2013 FOR IMPEDANCE MEASUREMENT. DEVICE MODE PROGRAMMED AS ADIR THROUGHOUT THE RECORD, SO ADDITIONAL AUTO LEAD DIAGNOSTIC INFORMATION ABOUT VENTRICULAR LEAD IMPEDANCE NOT AVAILABLE.

    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. CONCOMITANT PRODUCT: PRODUCT ID 4524-53, LEAD, IMPLANTED: (B)(6) 1992. (B)(4).

    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 THERE WAS VENTRICULAR LEAD WARNING DUE TO UNDERSENSED R WAVE. THE DEVICE WAS PROGRAMMED TO MODE ADIR. IT WAS CONFIRMED THAT THE LEAD IN QUESTION HAD NOT BEEN IN USE DUE TO LOW IMPEDANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464907 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention ADDR01 IPG