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

Model Number	SC-8336-70
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patients paddle lead migrated from the second cervical vertebral level to the top of the first thoracic vertebral level and was partially outside of the epidural space.Because of this, stimulation was unable to be adjusted.Therefore, the patient underwent a revision procedure during which the paddle lead was explanted and replaced with a new lead.The new lead was implanted in the same location as the previous leads original position in the cervical area.There were no reported patient complications postoperatively.The explanted paddle lead will not be returned as it was discarded by the medical facility.
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date.The device was not returned for analysis as it was discarded by the medical facility.As such, physical analysis was unable to be performed.However, it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that lead migration resulting in undesirable changes in stimulation and subsequent reduction in pain relief is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patients paddle lead migrated from the second cervical vertebral level to the top of the first thoracic vertebral level and was partially outside of the epidural space.Because of this, stimulation was unable to be adjusted.Therefore, the patient underwent a revision procedure during which the paddle lead was explanted and replaced with a new lead.The new lead was implanted in the same location as the previous leads original position in the cervical area.There were no reported patient complications postoperatively.The explanted paddle lead will not be returned as it was discarded by the medical facility.

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23000293
• Report Number: 3006630150-2025-07342
• Device Sequence Number: 9413463
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: (01)08714729832676(17)260307(10)7075880
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/20/2026

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: 03/07/2026
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7075880
• 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: 08/17/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 03/07/2024
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female