BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERA-I SR

    MDR report key: 22178533 · Received June 10, 2025

    Report

    Report Number
    2182208-2025-02814
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    October 23, 2006
    Report Date
    June 10, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. 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 WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: VERIFICATION OF IRRADIATION CONDITIONS OF X-RAYS THAT INFLUENCE IMPLANTABLE CARDIAC PACEMAKERS. NIHON HOSHASEN GIJUTSU GAKKAI ZASSHI. 2008. 64(7):795¿804 DOI: 10.6009/JJRT.64.795 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE EFFECTS OF X-RAY IRRADIATION ON IMPLANTABLE PULSE GENERATORS (IPGS). THE AUTHORS DESCRIBED IPGS WHICH WERE TESTED WITH X-RAY IRRADIATION IN PHANTOM BODY MODELS. THE DEVICES EXHIBITED SHORT PERIODS OF OVERSENSING. THE STATUS OF THE DEVICES IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718152 THERA-I SR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. 8961IU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown