BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z

    MDR report key: 12134876 · Received July 8, 2021

    Report

    Report Number
    2182208-2021-02748
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    November 1, 1997
    Report Date
    July 8, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS 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/(B)(6) YEARS OLD. 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: CLINICAL PERFORMANCE OF STEROID-ELUTING PACING LEADS WITH 1.2MM2 ELECTRODES. PACE. 1997. 20:2799-2809. 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 THE CLINICAL PERFORMANCE OF STEROID-ELUTING PACING LEADS WITH SMALLER ELECTRODES. OF 47 LEAD IMPLANTS, IT WAS REPORTED THAT 4 VENTRICULAR LEADS EXHIBITED UNSTABLE THRESHOLDS FOLLOWING IMPLANT BUT HAD SELF RESOLVED IN 1-3 DAYS POST-IMPLANT. 5 VENTRICULAR LEADS EXHIBITED A DECREASE IN IMPEDANCE. A CHRONIC INCREASE IN THRESHOLDS WAS ALSO OBSERVED OVERTIME AND IMPEDANCE WAS NOTED TO BE VARYING. DURING 1 VENTRICULAR IMPLANT, A PERFORATION OCCURRED. THE LEAD WAS WITHDRAWN AND SUCCESSFULLY REPOSITIONED. NO FURTHER INTERVENTION WAS REQUIRED. IT WAS ALSO REPORTED THAT ONE ATRIAL LEAD EXHIBITED UNSTABLE THRESHOLDS FOLLOWING IMPLANT BUT HAD SELF RESOLVED IN 1-3 DAYS POST-IMPLANT. A CHRONIC INCREASE IN THRESHOLDS WAS ALSO OBSERVED OVERTIME. WITH 1 ATRIAL IMPLANT THERE WAS A RISK OF DIAPHRAGMATIC STIMULATION WHICH WAS REPROGRAMMED. THE LEADS REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032301 CAPSURE Z PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 4533

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR