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

Model Number	SC-1216
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients implantable pulse generator (ipg) was not providing adequate pain relief.The patient underwent a spinal cord stimulator (scs) explant procedure.The explanted device was discarded.No further information has been obtained.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred a couple of years ago based on the date the manufacturer became aware of the event.Block d6b: explant date: procedure happened a couple f years ago.

• Brand Name: WaveWriter Alpha? 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50946734
• Report Number: 3006630150-2026-07224
• Device Sequence Number: 9499233
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 09/17/2024
• Device Model Number: SC-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 550158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 09/18/2022
• 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: 70 YR
• Patient Sex: Male