BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 25135440 · Received May 11, 2026

    Report

    Report Number
    2124215-2026-25285
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526539022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT CONTAINS ADDITIONAL INFORMATION IN SECTION B5 DESCRIBE EVENT OR PROBLEM, SECTION H1 INITIAL REPORTER FIRST NAME, H1 INITIAL REPORTER LAST NAME AND SECTION H6 DEVICE CODES. THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE CONCERNS FOR DROP IN BATTERY LONGEVITY ON THIS PACEMAKER DEVICE. THE BATTERY LONGEVITY DROPPED FROM 3YRS TO NOW REMAINING AT 1YR IN ABOUT 3-MONTH PERIOD. THE PATIENT HAD CALLED IN ASKING FOR SUPPORT AND TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED TO CHANGE THE COMMUNICATOR. TS STATED THAT THE COMMUNICATOR CONNECTED TO THE SERVER BUT DOES NOT RECEIVE THE INFORMATION FROM THE DEVICE. TS RECOMMENDED TROUBLESHOOTING OPTIONS. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS DEVICE WAS FOUND TO BE OPERATING IN SAFETY MODE AND WAS NOT ABLE TO BE LINKED WITH THE COMMUNICATOR. THE PLAN WAS TO HAVE THIS DEVICE REPLACED SOON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE CONCERNS FOR DROP IN BATTERY LONGEVITY ON THIS PACEMAKER DEVICE. THE BATTERY LONGEVITY DROPPED FROM 3YRS TO NOW REMAINING AT 1YR IN ABOUT 3-MONTH PERIOD. THE PATIENT HAD CALLED IN ASKING FOR SUPPORT AND TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED TO CHANGE THE COMMUNICATOR. TS STATED THAT THE COMMUNICATOR CONNECTED TO THE SERVER BUT DOES NOT RECEIVE THE INFORMATION FROM THE DEVICE. TS RECOMMENDED TROUBLESHOOTING OPTIONS. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433375 INGENIO PACEMAKERS LWP BOSTON SCIENTIFIC CORPORATION J177 102949 00802526539022

    Patients

    Seq Age Sex Outcome Treatment
    1