MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION WaveWriter Alpha? 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1216
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable pulse generator (ipg) and leads migrated and the patient was no longer experiencing adequate pain relief.The patient underwent a spinal cord stimulator (scs) replacement procedure and was doing well postoperatively.The explanted device components were not returned due to facility policy.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50.Serial number: (b)(6).Batch/lot number: 7174185.Model/catalog description: linear st lead kit 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2218-50.Serial number: (b)(6).Batch/lot number: 7174252.Model/catalog description: linear st lead kit 50 cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4316.Batch/lot number: 37454754.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).Sc-1216 (b)(6).Sc-2218-50 (b)(6).Sc-2218-50 (b)(6).Sc-4316 (bn/ln 37454754).Investigation results.The ipg, leads and anchoring device were not returned for analysis; therefore, a technical analysis could not be performed.The explanted device components were not returned due to facility policy.Device history record.It was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review.A labeling review was conducted and determined that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation (scs).The event is consistent with risks disclosed in the device labeling.Investigation conclusion.Based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• Brand Name: WaveWriter Alpha? 16
• 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 ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292
• MDR Report Key: 50101328
• Report Number: 3006630150-2026-05448
• Device Sequence Number: 9863060
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• UDI-Public: (01)08714729985082(17)271202(10)810578
• 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: 2025
• 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): 07/31/2026

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-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 810578
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 12/02/2025
• 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: 53 YR
• Patient Sex: Female