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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-8436-70 serial number: (b)(6) batch/lot number: 7076417 model/catalog description: coveredge 32 mri paddle lead 70cm unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced paddle migration out of the epidural space, resulting in loss of therapy coverage.During the procedure, the physician initially intended to reposition the paddle; however, upon accessing the implantable pulse generator (ipg) site, possible signs of infection like fluid were observed.It was noted that the patients incision had not fully healed.Cultures were obtained, and results revealed a staphylococcus aureus infection.The patient was prescribed antibiotics.As a result, the physician performed a revision procedure, including removal and replacement of the ipg and paddle for further evaluation.The products were not available for return and were not submitted for analysis.The patient is expected to make a full recovery.

• 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 ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292
• MDR Report Key: 25567820
• Report Number: 3006630150-2026-04258
• Device Sequence Number: 9796013
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: (01)08714729985075(17)271118(10)244011
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 244011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 07/20/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 07/13/2026; 07/28/2026
• Date Device Manufactured: 11/18/2025
• 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: Male