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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the spinal cord stimulation (scs) implant procedure in which the patient was under general anesthesia, the patient experienced loss of her motor functions with neuromonitoring.The physician chose to abort the procedure.It was assessed that the event was not believed to be device related, rather was due to the patient's anatomy.Once the procedure was over, the patients motor functions returned to baseline.The patient was doing well postoperatively.The explanted lead will not be returned as it was retained 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: 23694166
• Report Number: 3006630150-2025-11064
• Device Sequence Number: 10192339
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: (01)08714729832676(17)270519(10)7077482
• 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
• Report Date (Section B): 12/02/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7077482
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 05/19/2025
• 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: 76 YR
• Patient Sex: Female