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

Model Number	SC-8452-50
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Scar Tissue (2060); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: wavewriter alpha upn: m365sc12320 model: sc-1232 serial: (b)(6) lot: 555167.
Event or Problem Description
It was reported that the patient experienced jolting sensations.The device was reprogrammed which lessened the sensations.However, it was found that the spinal cord stimulation paddle lead migrated partially out of the epidural space at the proximal end.The patient underwent an explant procedure as the lead was unable to be repositioned due to the presence of excessive scar tissue.The patient fully recovered postoperatively.The devices were not returned as they were discarded by the medical facility.
Event or Problem Description
It was reported that the patient experienced jolting sensations.The device was reprogrammed which lessened the sensations.However, it was found that the spinal cord stimulation paddle lead migrated partially out of the epidural space at the proximal end.The patient underwent an explant procedure as the lead was unable to be repositioned due to the presence of excessive scar tissue.The patient fully recovered postoperatively.The devices were not returned as they were discarded by the medical facility.
Additional Manufacturer Narrative
Correction to the initial mdr in block b1, b3 and table h6.Additional suspect medical device component involved in the event: brand name: wavewriter alpha upn: m365sc12320, model: sc-1232, serial: (b)(6), lot: 555167, udi: (b)(4).

• Brand Name: COVEREDGE? X 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: 20303859
• Report Number: 3006630150-2024-06413
• Device Sequence Number: 8837979
• Product Code: LGW
• UDI-Device Identifier: 08714729995838
• UDI-Public: 08714729995838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 04/30/2026

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: 01/03/2025
• Device Model Number: SC-8452-50
• Device Catalogue Number: SC-8452-50
• Device Lot Number: 7070521
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 01/04/2023
• 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: 51 YR
• Patient Sex: Male