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	09/15/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Blocks b2 and b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-2408-56 serial number: (b)(6) batch/lot number: 21131350 model/catalog description: avista mri perc lead kit 56 cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2408-56 serial number: (b)(6) batch/lot number: 21131350 model/catalog description: avista mri perc lead kit 56 cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4319 serial number: n/a batch/lot number: 21042109 model/catalog description: clik x mri anchor unique identifier (udi) #: (b)(4).Model number/catalog number: fb-101-01 serial number: n/a batch/lot number: 21083175 model/catalog description: fixate suturing device unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient passed away.The cause of death was not related to the device or stimulation; however, the exact cause of death remains unknown.No further information has been obtained.

• 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: 50955116
• Report Number: 3006630150-2026-07246
• Device Sequence Number: 18749237
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• UDI-Public: (01)08714729985082(17)260107(10)595336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 01/07/2026
• Device Model Number: SC-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 595336
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/08/2024
• 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: 82 YR
• Patient Sex: Female