MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION AVISTA MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2408-74
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892); Wireless Communication Problem (3283); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation from the lead of the spinal cord stimulator (scs) system due to migration and was scheduled for a lead replacement procedure.Prior to the procedure, the patient stated that they began to experience difficulty charging of the implantable pulse generator (ipg), and was not able to connect to the clinician programmer, therefore, the physician decided to replace the ipg during the lead revision procedure.During the procedure an x-ray was taken and it confirmed that the lead had migrated to the thoracic level from the cervical levels.The procedure was completed successfully and the patient is doing well post operatively.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event brand name: wavewriter alpha, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 541256.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation from the lead of the spinal cord stimulator (scs) system due to migration and was scheduled for a lead replacement procedure.Prior to the procedure, the patient stated that they began to experience difficulty charging of the implantable pulse generator (ipg), the physician decided to replace the ipg during the lead revision procedure.During the procedure an x-ray was taken and it confirmed that the lead had migrated to the thoracic level from the cervical levels.The procedure was completed successfully and the patient is doing well post operatively.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: wavewriter alpha, upn: m365sc12320, model: sc-1232, serial: (b)(6).Sc-2408-74; (b)(6): the device was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.Sc-1232; (b)(6): the device was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Sc-2408-74; (b)(6): it states undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure and lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain are known risks of implanting a pulse generator as part of a system to deliver scs.Sc-1232; (b)(6): it states the charging distance between the charger and the ipg is between 0.5 to 2 cm.Centering the charger over the stimulator ensures the shortest charging time.In addition, a review of the charger handbook states to make sure the charger is well ventilated and centered over the stimulator.If you accidentally locate the patch in the wrong place, or if the charger belt moves out of alignment, the charger will start beeping.Use a new adhesive patch or readjust the belt to place the charger back into position.Do not confuse the end of charge signal a distinct double beep with the steady, continuous misalignment signal.Based on all available information, engineers are able to confirm the root cause of the event.The devices were returned, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is cause traced to known inherent risk of the device for the lead, and failure to follow instructions for the ipg.

• Brand Name: AVISTA MRI
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19507420
• Report Number: 3006630150-2024-03745
• Device Sequence Number: 7441469
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: 08714729904823
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2024
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 7075221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown