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

Model Number	SC-1060-B
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a replacement procedure because the implantable pulse generator (ipg) was no longer providing therapy.The device was retained by the facility and will not be returned for analysis.Postoperatively, therapy was resumed without complications.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.A labeling review did not reveal any anomalies as it states: undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure and persistent pain at the ipg or lead site are known risk with the use of spinal cord stimulation (scs).However, a labelling review found that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation (scs).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.Block b3: exact date unknown, approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a replacement procedure because the implantable pulse generator (ipg) was no longer providing therapy.The device was retained by the facility and will not be returned for analysis.Postoperatively, therapy was resumed without complications.

• Brand Name: SPECTRA WAVEWRITER?
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24652022
• Report Number: 3006630150-2026-01659
• Device Sequence Number: 10008551
• Product Code: LGW
• UDI-Device Identifier: 08714729953432
• UDI-Public: (01)08714729953432(17)200812(10)340551
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/12/2020
• Device Model Number: SC-1060-B
• Device Catalogue Number: SC-1060-B
• Device Lot Number: 340551
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 08/13/2018
• 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: 78 YR
• Patient Sex: Female