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

Model Number	SC-8436-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced thoracic pain at the paddle lead site since the initial implant procedure.The physician assessed that the pain may be due to the laminectomy performed to place the paddle lead.Additionally, the stimulation therapy initially worked well in the first five months, however, it has since decreased.Reprogramming was attempted however, the event persists, the patient underwent a thoracic radio frequency (rf) procedure and is content with the current situation.

• Brand Name: COVEREDGE MRI
• 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: 20892764
• Report Number: 3006630150-2024-08600
• Device Sequence Number: 18103627
• Product Code: LGW
• UDI-Device Identifier: 08714729995821
• UDI-Public: 08714729995821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 12/10/2024

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: 04/13/2025
• Device Model Number: SC-8436-70
• Device Catalogue Number: SC-8436-70
• Device Lot Number: 7074259
• 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: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 04/14/2023
• 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: 49 YR
• Patient Sex: Male