BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2377480 · Received December 15, 2011

    Report

    Report Number
    2649622-2011-18630
    Event Type
    Injury
    Date Received
    December 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE SHOWS A STEADY INCLINE SINCE PRIOR VISIT. IT WAS ALSO REPORTED THAT IMPEDANCE WAS TESTED SEVERAL TIMES AND IT WAS ALWAYS GREATER THAN 1900 OHMS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SENT FOR CHEST X-RAY AND WILL BE FOLLOWED AGAIN TO EVALUATE THE ATRIAL LEAD. ALSO, THE LEAD INTEGRITY ALERT (LIA) WAS DOWNLOADED PER THE PHYSICIAN'S STANDARD PROCEDURE. IT WAS LATER REPORTED THAT RECENT IMPEDANCE MEASUREMENT WAS THE HIGHEST NUMBER ON THE GRAPH SINCE PREVIOUS INTERROGATION. THEREFORE REGULAR FOLLOW UP WILL CONTINUE EVERY SIX MONTHS. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE SHOWS A STEADY INCLINE SINCE PRIOR VISIT. IT WAS ALSO REPORTED THAT IMPEDANCE WAS TESTED SEVERAL TIMES AND IT WAS ALWAYS GREATER THAN 1900 OHMS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SENT FOR CHEST X-RAY AND WILL BE FOLLOWED AGAIN TO EVALUATE THE ATRIAL LEAD. ALSO, THE LEAD INTEGRITY ALERT (LIA) WAS DOWNLOADED PER THE PHYSICIAN'S STANDARD PROCEDURE. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention