MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Avista? MRI; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2408-56
Medical Device Problem Codes	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead had demonstrated persistently high impedances since the time of implantation.The lead was left in situ because replacement was considered technically challenging due to the patients extreme obesity.The patient subsequently required magnetic resonance imaging (mri), and therefore, underwent an explant procedure to allow the mri to be performed.The patient recovered postoperatively.
Additional Manufacturer Narrative
Based on limited information and in the absence of device return, the cause of the high impedances was unable to be established.The lead has not been returned.As such, physical analysis has not been conducted in our laboratory.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review of the avista mri perc lead kit 56 cm hazard analysis was completed and confirmed that the event of high impedances was defined in the risk documentation.This event type has been accounted for during product risk analysis to support an acceptable risk-benefit for the product.The device was not returned for analysis.Review of the device history record did not identify any manufacturing deviations that could have contributed to the event.It was reported that the lead exhibited persistently high impedances since implantation; however, no additional device performance issues or clinical symptoms were reported.Therefore, based on the available information, boston scientific has determined that the cause of high impedances was unable to be established.
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead had demonstrated persistently high impedances since the time of implantation.The lead was left in situ because replacement was considered technically challenging due to the extreme obesity of the patient.The patient subsequently required magnetic resonance imaging (mri) and therefore underwent a system explant procedure to allow the mri to be performed.There were no reported issues with any of the devices other than the lead.The patient recovered postoperatively.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 24391919
• Report Number: 3006630150-2026-01000
• Device Sequence Number: 13417362
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)260912(10)7085399
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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: 09/12/2026
• Device Model Number: SC-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 7085399
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 08/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/23/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: Male