MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Spectra WaveWriter?; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-1160
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients implantable pulse generator (ipg) was experiencing loss of stimulation and pain the leads had high impedances.The patient underwent an implantable pulse generator (ipg) replacement procedure and was doing well postoperatively.The explanted device was not returned.
Additional Manufacturer Narrative
Block 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-2317-70 serial number: 5070318 batch/lot number: 5070318 model/catalog description: infinion cx lead kit, 70cm unique identifier (udi) #: (01)08714729861638(17)200626(10)5070318(21)5070318 model number/catalog number: sc-2317-70 serial number: 5072038 batch/lot number: 5072038 model/catalog description: infinion cx lead kit, 70cm unique identifier (udi) #: (01)08714729861638(17)200704(10)5072038(21)5072038 investigation results, media review, device analysis the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.-a review was not completed of the device history records (dhr) for the device.The dhr review cannot be performed as no batch number was reported and a ship history cannot be performed since the upn was not reported.Labeling review review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review a risk review was conducted and confirmed that the reported events are recognized within the products risk management documentation.These event types have been previously evaluated and are considered within the acceptable benefit-risk profile of the device.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50929783
• Report Number: 3006630150-2026-07177
• Device Sequence Number: 21514086
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 06/26/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 338501
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 06/27/2018
• 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: 60 YR
• Patient Sex: Female