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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Pain (1994); Fluid Discharge (2686)
Date of Event	05/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred when the device was explanted.Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 585377.
Event or Problem Description
It was reported that the patient had a staph infection in the upper incision where the paddle was placed.Symptoms of soreness, redness, puffiness, and some yellow and white discharge were noted.The patient underwent a full system explant and was prescribed antibiotics.The explanted devices will not be returned.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred when the device was explanted.Correction to initial emdr in blocks f10 and h6.Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that while on vacation the patient experienced a staphylococcus infection in the upper incision where the spinal cord stimulation (scs) paddle lead was placed.Symptoms of soreness, redness, puffiness, and some yellow and white discharge were noted.The patient went to an e.R.And underwent a procedure in which the entire scs system was explanted.In addition, the patient was prescribed antibiotics.The patient could not remember the name of the physician or hospital where the explant took place, and therefore, the explanted devices will not be returned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that while on vacation the patient experienced a staphylococcus infection in the upper incision where the spinal cord stimulation (scs) paddle lead was placed.Symptoms of soreness, redness, puffiness, and some yellow and white discharge were noted.The patient went to an e.R.And underwent a procedure in which the entire scs system was explanted.In addition, the patient was prescribed antibiotics.The patient could not remember the name of the physician or hospital where the explant took place, and therefore, the explanted devices will not be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred when the device was explanted.Correction block e1 additional suspect medical device component involved in the event: product family: scs-ipg-r-mri upn: m365sc12320 model: sc-1232 serial: (b)(6) batch: 585377 udi: (b)(4).With all available information, boston scientific concludes that the reported staphylococcus infection is a known inherent risk as documented in the instructions for use (ifu), however, the cause of the reported impaired healing is unable to be established.The paddle lead and ipg have not been returned by the medical facility as the patient could not remember the name of the physician or hospital where the explant took place, and therefore, the explanted devices will not be returned.As such, physical analysis has not been conducted in our laboratory.A review of the device history record (dhr) for the devices was performed.The review of the dhr identified that there were no process-related non-conformances, scrap, or rework performed during the production that could explain the event.The review ensures each device meets specifications prior to release for use.There is no indication that the device manufacturing process contributed to the reported complaint.The labeling review performed did not reveal any anomalies.Per the instructions for use (ifu), possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis are known risks associated with implantation of a spinal cord stimulation (scs) system.The reported event of a staphylococcus infection at the paddle lead incision site, resulting in explant of the spinal cord stimulation (scs) system, is confirmed; however, a device malfunction or performance issue is not confirmed based on the available information.The device was not returned for analysis as such, physical analysis has not been conducted in our laboratory.The device history record review did not identify any manufacturing deviations that could have contributed to the event.Labeling review identified that infection is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation, however insufficient information is available to determine the underlying cause of the infection.

• 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: 19652344
• Report Number: 3006630150-2024-04233
• Device Sequence Number: 6745477
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2026

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: 11/15/2025
• Device Model Number: SC-8436-50
• Device Catalogue Number: SC-8436-50
• Device Lot Number: 7085080
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 04/15/2026; 05/26/2026
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 04/29/2026; 06/18/2026
• Date Device Manufactured: 11/16/2023
• 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: 40 YR
• Patient Sex: Female