BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDXTM MAPPING SYSTEM

    MDR report key: 19986181 · Received August 14, 2024

    Report

    Report Number
    2124215-2024-49945
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. INITIAL REPORTER PHONE (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE COMMUNICATION BETWEEN THE RHYTHMIA SCREEN WAS FROZEN DURING MAPPING. THE COMMUNICATION BETWEEN THE SIS AND THE WS WAS INTERRUPTED. RESTARTED THE SIS AND WS SEVERAL TIMES, REPLACED THE FO THREE TIMES, HOWEVER, THE COMMUNICATION BETWEEN THE SIS AND WS WAS NOT ACHIEVED. ISSUE WAS NOT ABLE TO BE RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED BUT PHYSICIAN MANAGED TO FINISH PROPERLY THE PROCEDURE. USING ANOTHER CPU TO RESOLVE THE ISSUE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE COMMUNICATION BETWEEN THE RHYTHMIA SCREEN WAS FROZEN DURING MAPPING. THE COMMUNICATION BETWEEN THE SIS AND THE WS WAS INTERRUPTED. RESTARTED THE SIS AND WS SEVERAL TIMES, REPLACED THE FO THREE TIMES, HOWEVER, THE COMMUNICATION BETWEEN THE SIS AND WS WAS NOT ACHIEVED. ISSUE WAS NOT ABLE TO BE RESOLVED. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT AND HAD TO BE CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993351 RHYTHMIA HDXTM MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE NMD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown