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

Model Number	SC-1232
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation.The patient underwent a procedure wherein the ipg and spinal cord stimulator (scs) leads were explanted.The patient was doing well postoperatively and the explanted devices were retained by the medical facility and will not be returned.
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: 7104214 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: 7104321 model/catalog description: linear st lead kit 50 cm unique identifier (udi)#: (b)(4).Model number/catalog number: sc-4318 batch/lot number: 28820370 model/catalog description: linear st lead kit 50 cm unique identifier (udi)#: (b)(4).Investigation results: all explanted devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that all devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: all explanted devices were not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to all complaints.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code cause not established will be used.

• Brand Name: WaveWriter Alpha?
• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50912854
• Report Number: 3006630150-2026-07139
• Device Sequence Number: 5778539
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/28/2026

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: 08/26/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 521394
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 08/26/2021
• 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: 80 YR
• Patient Sex: Female