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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient passed away.The cause of death is not believed to be related to the device or stimulation; however, this has not been confirmed.No further information has been obtained.
Additional Manufacturer Narrative
Block b2 and b3: approximation: the event occurred three weeks prior to the aware date.Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50, serial number: (b)(6), batch/lot number: 7091167, 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: 7091208, model/catalog description: linear st lead kit 50 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318, serial number: n/a, batch/lot number: 27083436, model/catalog description: clik x anchor sterile kit, unique identifier (udi) #: (b)(4).

• 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 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: 50927841
• Report Number: 3006630150-2026-07171
• Device Sequence Number: 10735229
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 07/25/2024
• Device Model Number: SC-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 545377
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 07/26/2022
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Female