MAUDE Adverse Event Report: BIOTRONIK RESILIENCE 75TR; LEAD

Model Number	457851
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Lead attempted but not implanted.Md was attempting to place lead at level t5-6 where needle was placed when the lead seemed to have gotten impacted by the ligament then the physician attempted to remove the needle and the lead.One contact of the lead remained in the patient epidural space in the t5 area while the remaining lead and needle were removed.No complication occurred due to this incident.Therapy was activated with good pain relief as trial continues.Patient will be sent to neurosurgery for removal of the broken contact when the permanent system is implanted.

• Brand Name: RESILIENCE 75TR
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK; 6024 jean road; lake oswego OR 97035
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24967127
• Report Number: 3027063190-2026-00141
• Device Sequence Number: 18749046
• Product Code: LGW
• UDI-Device Identifier: 04035479170349
• UDI-Public: (01)04035479170349(17)271231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P210037
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 457851
• Device Catalogue Number: 457851
• 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: 04/22/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown