BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 6009839 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-13591
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4524 LEAD, IMPLANTED (B)(6) 1999. 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.

    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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING THRESHOLDS AND THAT PACING IMPEDANCE HAD FALLEN TO A LOW RANGE. THE LEAD WAS 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
    655091 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ADDR01IPG