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

Model Number	SC-1416
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Battery Problem (2885)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with a wavewriter alpha prime was a high energy user and the patient's ipg had reached end of life.The physician found an infection at the pocket site during a revision procedure and decided to explant the ipg including the spinal cord stimulator paddle (scs) lead.
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: model number/catalog number: sc-8216-50, serial number: (b)(6), batch/lot number: 7079610, model/catalog description: artisan lead 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 this device 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.A sterilization record review (srr) was performed, and the review identified no sterilization-related findings that could be reasonably associated with the reported 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? Prime 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 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: 50866067
• Report Number: 3006630150-2026-07023
• Device Sequence Number: 13427216
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/23/2026

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 Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 235151
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 01/22/2025
• 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: 82 YR
• Patient Sex: Female