BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z

    MDR report key: 12062952 · Received June 24, 2021

    Report

    Report Number
    2182208-2021-02568
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    November 1, 1999
    Report Date
    June 24, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/74 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: STABLE ELECTRICAL PERFORMANCE OF HIGH EFFICIENCY PACING LEADS HAVING SMALL SURFACE, STEROID-ELUTING PACING ELECTRODES. PACE. 1999. VOL. 22. 1599-1603. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE ARTICLE REPORTS RIGHT VENTRICULAR (RV) LEADS WHICH EXHIBITED MICRO DISLODGEMENTS WITH SUDDEN INCREASES IN THRESHOLD. THE LEADS WERE REPROGRAMMED. THERE WERE RIGHT ATRIAL (RA) LEADS WHICH ALSO EXHIBITED MICRO DISLODGEMENTS WITH FAILURE TO CAPTURE AND GRADUAL RISES IN THRESHOLD. THE STATUS/DISPOSITION OF THE LEADS APPEARS TO BE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953066 CAPSURE Z PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 5534

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR