BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 15451118 · Received September 19, 2022

    Report

    Report Number
    3006630150-2022-04861
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 25, 2022
    Report Date
    March 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    SC-8120-70 SN: (B)(6) THE RETURNED LEAD WAS ANALYZED, AND VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO THREE PIECES APPROXIMATELY 23.5 CENTIMETERS FROM THE PROXIMAL END OF THE LEAD. THE PADDLE PORTION OF THE LEAD WAS NOT RETURNED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF LEAD DAMAGE HAS BEEN CONFIRMED. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE TENSILE FORCE WHEN IT MIGRATED, CAUSING DAMAGE TO THE LEAD BODY INSULATION, CABLE FRACTURES. DUE TO THE DAMAGE TO THE LEAD INSULATION, BODY FLUIDS WENT IN THE LEAD BODY, CAUSING THE REPORTED DISCOLORATION OF THE CABLES. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE. HOWEVER, BASED ON THE IFU, LEAD MIGRATION IS ONE OF THE POSSIBLE RISKS OF IMPLANTING PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. THE REPORTED LEAD MIGRATION RESULTED IN THE REPORTED LOSS OF STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND DURING THE REVISION IT WAS FOUND OUT THAT THE LEAD HAD MISSING COATING, BROKEN WIRES, DISCOLORATION OF THE WIRES AND DISCOLORATION OF THE TISSUE. THE BROKEN PARTS OF THE LEAD WERE EXPLANTED AND THE REMAINING PART WAS NOT REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND DURING THE REVISION IT WAS FOUND OUT THAT THE LEAD HAD MISSING COATING, BROKEN WIRES, DISCOLORATION OF THE WIRES AND DISCOLORATION OF THE TISSUE. THE BROKEN PARTS OF THE LEAD WERE EXPLANTED AND THE REMAINING PART WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874373 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 259362A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention