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 Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a lead fracture which was confirmed with imaging.It was also noted that the lead had migrated.The patient underwent a revision procedure wherein lead extensions were added to prevent the lead from pulling out again.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-paddle leads upn: m365sc8336700 model: sc-8336-70 serial: (b)(6).Batch: 7075021 udi: (b)(4).
Event or Problem Description
It was reported that the patient had a lead fracture which was confirmed with imaging.It was also noted that the lead had migrated.The patient underwent a revision procedure wherein lead extensions were added to prevent the lead from pulling out again.Additional information was received that the fractured lead was replaced.
Event or Problem Description
It was reported that the patient had a lead fracture which was confirmed with imaging.It was also noted that the lead had migrated.The patient underwent a revision procedure wherein lead extensions were added to prevent the lead from pulling out again.Additional information was received that the fractured lead was replaced.Additional information was received that the patient was doing well postoperatively.The explanted device 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: 22980733
• Report Number: 3006630150-2025-07258
• Device Sequence Number: 9540834
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: (01)08714729832676(17)270504(10)7077369
• 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: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 10/14/2025

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 Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7077369
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 09/26/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/15/2025
• Date Device Manufactured: 05/04/2025
• 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: 69 YR
• Patient Sex: Female