MAUDE Adverse Event Report: BIOTRONIK RESILIENCE 75TR; LEAD

Model Number	457851
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Trauma was caused to the lead when the physician was trying to advance the needle into the epidural space while the lead was partially advanced beyond the needle tip.Electrode 1 and 2 broke off the lead while the physician was removing the lead and needle.The two electrodes are outside the epidural space and the physician plans on removing them when the patient has the permanent implant.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: RESILIENCE 75TR
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK; 6024 jean road; lake oswego 97035
• Manufacturer Contact: 6024 jean road; lake oswego 97035 ; 8772459800
• MDR Report Key: 19416741
• Report Number: 3027063190-2024-00072
• Device Sequence Number: 15580234
• Product Code: LGW
• UDI-Device Identifier: 04035479170349
• UDI-Public: (01)04035479170349(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Expiration Date: 03/31/2025
• Device Model Number: 457851
• Device Catalogue Number: 457851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR
• Patient Sex: Unknown