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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was prescribed with medication due to an infection at the lead site.Patient had a lot of drainage, and her midline incision was slightly open.The physician believed that the infection was not device or procedure related, and the cause was unknown.The patient was experiencing a loss of stimulation due to a lead migration.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient was prescribed with medication due to an infection at the lead site.Patient had a lot of drainage, and her midline incision was slightly open.The physician believed that the infection was not device or procedure related, and the cause was unknown.The patient was experiencing a loss of stimulation due to a lead migration.Additional information was received that the patient underwent a lead replacement 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22084996
• Report Number: 3006630150-2025-03662
• Device Sequence Number: 6935941
• Product Code: LGW
• UDI-Device Identifier: 08714729995814
• UDI-Public: (01)08714729995814(17)270218(10)7090270
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 07/24/2025

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-8436-50
• Device Catalogue Number: SC-8436-50
• Device Lot Number: 7090270
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 02/18/2025
• 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; Other
• Patient Age: 22 YR
• Patient Sex: Unknown