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

Model Number	SC-1160
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent explant of the system due to patient dissatisfaction with therapy and persistent implantable pulse generator (ipg) pocket pain.No patient complications were reported.The onset date of the issue was unavailable.The patient underwent explant of the system and was reported to be doing well postoperatively.The explanted devices were disposed of per facility policy and were not returned for analysis.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-2317-50 serial number: (b)(6) batch/lot number: 5130508 model/catalog description: infinion cx lead kit, 50cm unique identifier (udi) #: (b)(4) model number/catalog number: sc-2317-50 serial number: (b)(6) batch/lot number: 5130659 model/catalog description: infinion cx lead kit, 50cm unique identifier (udi) #: (b)(4).

• Brand Name: Spectra WaveWriter?
• 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; cashel road; clonmel E91T8 62; EI E91T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50934988
• Report Number: 3006630150-2026-07199
• Device Sequence Number: 9509226
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 03/12/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 352122
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/13/2019
• 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: 82 YR
• Patient Sex: Male