BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX?

    MDR report key: 25118012 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24941
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729938736
    PMA / PMN Number
    K162793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAGNETIC LOCATION WAS LOST AND CATHETER COULD NOT BE VISUALIZED WHILE USING A LOCALIZATION GENERATOR, ADDITIONALLY ERROR 1105-2 AND 1113-2 WERE DISPLAYED. PICTURE PROVIDED SHOWED ERROR CODE 1318. NO PATIENT COMPLICATIONS OCCURRED. CASES WERE POSTPONED UNTIL REPLACEMENT. THERE IS NOT ANY INDICATION IF THE DEVICE WILL BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182368 RHYTHMIA HDX? COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION M004RH20010 08714729938736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown