MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION COVEREDGE? X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-8352-70
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation from their spinal cord stimulation (scs) system.The patients' programs were optimized however the issue persisted.Imaging was performed which revealed the paddle lead migrated out of the epidural space and folded back on itself.The patient underwent a revision procedure in which the paddle lead was replaced.There were no patient complications.The patient is doing well postoperatively and reported good pain coverage.
Additional Manufacturer Narrative
Visual inspection of the returned lead revealed that the lead was cleanly cut into five pieces, and four of the proximal ends of the leads were not returned.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.No other anomalies were identified on the returned portion of the lead.A labeling review was conducted and determined that the reported event of lead migration and inadequate stimulation are known inherent risks associated with implanting a pulse generator as part of a system to deliver spinal cord stimulation.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation from their spinal cord stimulation (scs) system.The patients' programs were optimized however the issue persisted.Imaging was performed which revealed the paddle lead migrated out of the epidural space and folded back on itself.The patient underwent a revision procedure in which the paddle lead was replaced.There were no patient complications.The patient is doing well postoperatively and reported good pain coverage.

• Brand Name: COVEREDGE? X 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23357598
• Report Number: 3006630150-2025-09404
• Device Sequence Number: 8824137
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: (01)08714729832690(17)190602(10)20688521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 06/02/2019
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 20688521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2017
• 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 Sex: Unknown