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	Charging Problem (2892); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a revision procedure in which the leads and implantable pulse generator (ipg) were explanted and replaced due to migration and charging difficulties, respectively.Electrocautery was used.The ipg and leads were retained by the hospital and will not be returned for analysis.Postoperatively, the patient was doing well.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: product family: scs-ipg-r-mri.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Additional Manufacturer Narrative
The device sc-1232; (b)(6) was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: unable to exclude device problem.The device sc-2408-74; (b)(6) was not returned for analysis; therefore, a technical analysis could not be performed.A labeling review did not reveal any anomalies as it states that lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief is a known risk with the use of spinal cord stimulation (scs).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: known inherent risk of device.The device sc-2408-74; (b)(6) was not returned for analysis; therefore, a technical analysis could not be performed.A labeling review did not reveal any anomalies as it states that lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief is a known risk with the use of spinal cord stimulation (scs).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: known inherent risk of device.B3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-ipg-r-mri.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: 790708.Udi: (b)(4).Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 7080404.Udi: (b)(4).
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a revision procedure in which the leads and implantable pulse generator (ipg) were explanted and replaced due to migration and charging difficulties, respectively.Electrocautery was used.The ipg and leads were retained by the hospital and will not be returned for analysis.Postoperatively, the patient was doing well.

• 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: 24163663
• Report Number: 3006630150-2026-00487
• Device Sequence Number: 18539190
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: (01)08714729904823(17)270626(10)7080329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 7080329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 06/26/2025
• 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 Age: 71 YR
• Patient Sex: Female