MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-8352-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Swelling/ Edema (4577)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pus, redness, and swelling at the lead insertion site.The patients wife had been treating this on her own with peroxide.The patient was administered antibiotics by their general practitioner, and later administered a different type of antibiotics from their spinal cord stimulation physician.The physician assessed that the patient had an infection.The device and procedure are contributing factors to the infection, along with the fact that the patient refused to report for follow-up visits as instructed by the implant team.A culture was taken which confirmed staphylococcus infection.The patient underwent a procedure in which the entire system was explanted.The explanted devices will not be returned as they were discarded at the medical facility.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event product family scs-ipg-r-mri, upn m365sc12320, model sc-1232, serial-lot (b)(6), batch (b)(6).

• Brand Name: COVEREDGE X 32
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 19076788
• Report Number: 3006630150-2024-02202
• Device Sequence Number: 6030104
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: 08714729832690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 04/09/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/21/2024
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 7070633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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 Sex: Unknown