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 Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Implant Pain (4561); Bladder Dysfunction (4881)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients implantable pulse generator (ipg) has migrated causing pain at the implant site.The patient underwent a revision procedure, upon impedance check, found that one lead was completely fractured with high impedances, physician decided to swap the ipg remove the bad lead and insert a new lead.The patient was doing well postoperatively.The explanted device was not returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: infinion cx lead kit, 50cm, model number: sc-2317-50, upn: m365sc2317500, serial: (b)(6), batch: 7078682, udi: (b)(4).

• 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50915507
• Report Number: 3006630150-2026-07149
• Device Sequence Number: 5330474
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 11/10/2024
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 554222
• 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: 11/11/2022
• 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: 53 YR
• Patient Sex: Female