MAUDE Adverse Event Report: BIOVENTUS LLC TALISMANN; STIMULATOR, PERIPHERAL NERVE, IMPLANTED

Model Number	TM-1000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388); Skin Infection (4544)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient experienced localized pain and discharge approximately 10 days post implant of the stimrouter device.The patient also experienced a lack of pain relief from stimulation.The patient sent photos to the sales rep and the physician who prescribed keflex at a frequency of four times per day.At the patients in person follow-up appointment, the physician recommended an explant due to an infection around the lead, which the patient did not want at that time.The physician and the patient decided to increase the incision site to allow for drainage and prescribed a new oral antibiotic to control the infection and salvage the implant.Photos indicate redness skin breakdown/opening, and possible drainage and a lack of healing from the surgical wound.The skin reaction appeared to be most consistent with a post-operative infection/cellulitis.Ct scan completed on (b)(6) 2026 identified a metallic foreign body consistent with the implanted device in the distal lateral thigh with associated fat stranding, suggestive of localized inflammation.No organized abscess, fracture, or destructive bony lesion was identified.Follow up from customer service revealed that the infection was cleared and treatment would resume.Medical assessment of the reported event is ongoing.The investigation of the involved talismann implant kit production lot records is ongoing.
Event or Problem Description
Patient experienced localized pain and discharge approximately 10 days post implant of the stimrouter pns device.The patient also experienced a lack of pain relief from stimulation.The patient sent photos to the sales rep and the physician who prescribed keflex at a frequency of four times per day.At the patients in person follow-up appointment, the physician recommended an explant due to an infection around the lead, which the patient did not want at that time.The physician and the patient decide to increase the incision site to allow for drainage and prescribed a new oral antibiotic to control the infection and salvage the implant.The implant of the talismann model tm-1000 pns device utilized the stimrouter model st2-1000 stimrouter implantable lead and lead introducer kit, sterile.This report is for the talismann model tm-1000 pns device.

• Brand Name: TALISMANN
• Common Device Name: STIMULATOR, PERIPHERAL NERVE, IMPLANTED
• Manufacturer (Section D): BIOVENTUS LLC; 4721 emporer blvd suite 100; durham NC 27703
• Manufacturer (Section G): RESOLUTION MEDICAL LLC; 42 northern stacks dr; fridley MN 55421
• Manufacturer Contact: sageev george ; 4721 emporer blvd suite 100; durham, NC 27703 ; 9195397245
• MDR Report Key: 25654431
• Report Number: 3027669735-2026-00001
• Device Sequence Number: 18590463
• Product Code: GZF
• UDI-Device Identifier: 00816986020549
• UDI-Public: 00816986020549
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K243678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: TM-1000
• Device Lot Number: L-1306381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STIMROUTER ST2-1000.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female