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

Model Number	SC-1416
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	01/13/2026
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 stimulation; however, it remains unconfirmed.No further information has been obtained.The implantable pulse generator (ipg) was returned and will undergo analysis.
Additional Manufacturer Narrative
Additional product(s) in device system: model number/catalog number: sc-2218-70.Serial number: (b)(6).Batch/lot number: 5016133.Model/catalog description: linear st lead kit 70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2218-70.Serial number: (b)(6).Batch/lot number: 5019746.Model/catalog description: linear st lead kit 70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318.Serial number: n/a.Batch/lot number: 20203257.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).

• Brand Name: WaveWriter Alpha? Prime 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: 50931537
• Report Number: 3006630150-2026-07187
• Device Sequence Number: 10759726
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• 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: Consumer,Company Representative
• 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: 10/08/2024
• Device Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 213473
• 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: 10/09/2022
• 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: 83 YR
• Patient Sex: Female