BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z

    MDR report key: 1861607 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10014
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 PATIENT WAS ON A HOLTER MONITOR ON (B)(6), 2010 THAT INDICATED OVERSENSING/SENSING FAILURE. THE DEVICE WAS CHECKED ON (B)(6), 2010 AND NO ANOMALIES WERE FOUND. OVERSENSING COULD NOT BE REPRODUCED BY CHANGING THE PATIENT POSTURE, MANIPULATING POCKET AREA OR ARM MOVEMENTS. THE PHYSICIAN SUSPECTS LEAD FRACTURE DUE TO LONG USAGE, BASED ON GREATER THAN 2000OHMS IMPEDANCE SHOWN IN THE LEAD TREND. THE PATIENT WILL BE REFERRED TO ANOTHER HOSPITAL FOR REVISION PROCEDURE. THE 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 Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5033 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other