MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION CoverEdge? MRI; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-8436-50
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3- approximated based on the date of explant.Additional suspect medical device component involved in the event: model number/catalog number: sc-1432 serial number: (b)(6) batch/lot number: 216059 model/catalog description: wavewriter alpha prime 32 ipg kit unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead was torn off in a violent car crash.It was unknown if car accident was device related.As a result, the stimulation setting had to be increased to 100 to achieve stimulation, which caused pain.The patient underwent spinal cord stimulator (scs) explant procedure.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25892716
• Report Number: 3006630150-2026-05146
• Device Sequence Number: 9818593
• Product Code: LGW
• UDI-Device Identifier: 08714729995814
• UDI-Public: (01)08714729995814(17)250115(10)7081022
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2025
• Device Model Number: SC-8436-50
• Device Catalogue Number: SC-8436-50
• Device Lot Number: 7081022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 09/09/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/17/2026; 10/02/2026
• Date Device Manufactured: 01/16/2023
• 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: 52 YR
• Patient Sex: Female