BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 19967031 · Received August 12, 2024

    Report

    Report Number
    3006630150-2024-05266
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 17, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    GXD
    UDI-DI
    00813250010107
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: GXD, GXI.

    Additional Manufacturer Narrative · 0

    CORRECTION THE INITIAL MDR: THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FOR A BROKEN ELECTRODE DOES NOT MEET REPORTING CRITERIA. THE BROKEN ELECTRODE WAS DISCOVERED AFTER THE PROCEDURE WAS COMPLETED; AS SUCH, THERE WAS NO REPORTED HARM TO THE PATIENT. AS THERE WAS NO SERIOUS INJURY, THE EVENT SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: GXD, GXI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED. AFTER FURTHER REVIEW, THE BROKEN ELECTRODE WAS DISCOVERED POST-PROCEDURE AND DID NOT OCCUR INSIDE THE PATIENT. AS SUCH, THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174571 NA GENERATOR, LESION, RADIOFREQUENCY GXD BOSTON SCIENTIFIC NEUROMODULATION CORPORATION CSK-TC10 30952831 00813250010107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other