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

Model Number	SC-1432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a spinal cord stimulator (scs) system explant procedure due to infection.The explanted device components were not returned.No further information could be obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred approximately two years prior to the date manufacturer became aware of the event.Block d6b: explant date: 2 years ago.Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50.Serial number: (b)(6).Batch/lot number: (b)(6).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: (b)(6).Model/catalog description: linear st lead kit 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4316.Serial number: n/a.Batch/lot number: 30626338.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).

• Brand Name: WaveWriter Alpha? Prime
• 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: 50837868
• Report Number: 3006630150-2026-06934
• Device Sequence Number: 10051230
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 08/17/2024
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 212522
• 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: 09/21/2026
• Date Device Manufactured: 08/18/2022
• 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: 73 YR
• Patient Sex: Female