MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION CoverEdge? 32; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-8336-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the leads migrated which was confirmed with imaging and experiencing loss of stimulation.The patient underwent a lead replacement procedure and was doing well postoperatively.
Event or Problem Description
It was reported that the leads migrated which was confirmed with imaging and experiencing loss of stimulation.The patient underwent a lead replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-1232, serial number: (b)(6), batch/lot number: 804285, model/catalog description: wavewriter alpha 32 ipg kit, unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
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.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: CoverEdge? 32
• 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; road 698, lot no. 12; dorado PR 00646 -260
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25708333
• Report Number: 3006630150-2026-04595
• Device Sequence Number: 16113305
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: (01)08714729832669(17)270114(10)7089883
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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 Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7089883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: Not provided; 08/24/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/17/2026
• Date Device Manufactured: 01/14/2025
• 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: 53 YR
• Patient Sex: Female