BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 6007303 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-12897
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND NON CAPTURE AT MAX OUTPUTS. THE LEAD WAS EXPLANTED 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
    655952 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 402452

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 8340 IPG