MAUDE Adverse Event Report: BIOTRONIK RESILIENCE 55TR; LEAD

Model Number	457850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported severe pain under epg site.The epg and leads were removed one day prior to scheduled trial completion.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The lead 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 55TR
• 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: 17850889
• Report Number: 3027063190-2023-00013
• Device Sequence Number: 17865024
• Product Code: LGW
• UDI-Device Identifier: 04035479170356
• UDI-Public: (01)04035479170356(17)250531
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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 Expiration Date: 05/31/2025
• Device Model Number: 457850
• Device Catalogue Number: SEE MODEL NO.
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/27/2023
• 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 Sex: Unknown