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 Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2408-56 serial number: (b)(6).Batch/lot number: 19918951 model/catalog description: avista mri perc lead kit 56 cm unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient experienced inadequate pain relief from their spinal cord stimulation (scs) leads.The physician was not certain if the lead position changed but noted that the leads were placed more cephalad than usual.The physician also mentioned that the lead position could have been a factor in the reduced pain relief effect.The patient requested the leads be upgraded.Therefore the patient underwent a revision procedure in which the leads were replaced with a paddle lead.The patient was doing well postoperatively.
Event or Problem Description
It was reported that the patient experienced inadequate pain relief from their spinal cord stimulation (scs) leads.The physician was not certain if the lead position changed but noted that the leads were placed more cephalad than usual.The physician also mentioned that the lead position could have been a factor in the reduced pain relief effect.The patient requested the leads be upgraded.Therefore the patient underwent a revision procedure in which the leads were replaced with a paddle lead.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Block b3: date approximate.Additional suspect medical device component involved in the event: model number/catalog number: sc-2408-56.Serial number: (b)(6).Batch/lot number: 19918951.Model/catalog description: avista mri perc lead kit 56 cm.Unique identifier (udi) #: (b)(4).

• 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; 25155 rye canyon loop; valencia CA 91355 ; * 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24596152
• Report Number: 3006630150-2026-01495
• Device Sequence Number: 8698302
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)181103(10)19913489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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 Expiration Date: 11/03/2018
• Device Model Number: SC-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 19913489
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 11/03/2016
• 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: 76 YR
• Patient Sex: Male