BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 4141280 · Received October 3, 2014

    Report

    Report Number
    2649622-2014-10404
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    January 9, 1991
    Report Date
    December 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL THAT THE LEAD WAS PRESUMED TO HAVE BEEN REPLACED DUE TO A MALFUNCTION BUT THIS WAS NOT CONFIRMED AS THE LEAD REVISION WAS PERFORMED BY ANOTHER PHYSICIAN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620878 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 400458

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| R 8340 IPG