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	Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing complications like shocking and poor pain relief despite multiple device optimizations.
Additional Manufacturer Narrative
Block b3: exact date approximated 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-2218-50.Serial number: (b)(6).Batch/lot number: 7146670.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: 7146168.Model/catalog description: linear st lead kit 50 cm.Unique identifier (udi)#: (b)(4).

• 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: 50802941
• Report Number: 3006630150-2026-06854
• Device Sequence Number: 18367799
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• UDI-Public: (01)08714729985068(17)260617(10)228862
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 06/17/2026
• Device Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 228862
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/17/2024
• 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: 69 YR
• Patient Sex: Male