MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC EPIMED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	105-1314
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent trial procedure, during the procedure physician was unable to gain access to the epidural space.Per physician, this issue was not procedure or device related.The patient was doing well postoperatively, and the device was not returned.
Additional Manufacturer Narrative
This 3500a mdr was submitted in error.The regulatory reporting for this device is the responsibility of the manufacturer (epimed international, inc) and not boston scientific.Therefore, please note that this event should not have been reported on a 3500a mdr form by boston scientific.
Event or Problem Description
It was reported that the patient underwent trial procedure, during the procedure physician was unable to gain access to the epidural space.Per physician, this issue was not procedure or device related.The patient was doing well postoperatively, and the device was not returned.

• Brand Name: EPIMED
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC; 13958 diplomat drive; farmers branch TX 75234
• Manufacturer (Section G): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23534339
• Report Number: 3006630150-2025-10309
• Device Sequence Number: 13032505
• Product Code: LGW
• UDI-Device Identifier: 00818788020079
• UDI-Public: (01)00818788020079(17)300814(10)121413787
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/11/2026

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: Health Professional
• Device Model Number: 105-1314
• Device Catalogue Number: 105-1314
• Device Lot Number: 121413787
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 08/28/2025
• 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
• Patient Age: 77 YR
• Patient Sex: Female