MAUDE Adverse Event Report: BIOTRONIK RESILIENCE 55TR; LEAD

Model Number	457850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Trial system was put into place on (b)(6) 2023.On (b)(6) 2023 high impedances were seen.The device header was changed out on that day with no change to the impedances.During the scheduled lead pull on (b)(6) 2023 this lead was found dislodged almost completely out of the body and the other lead was completely out of the body.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available 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: 17007686
• Report Number: 3027063190-2023-00002
• Device Sequence Number: 6285902
• Product Code: LGW
• UDI-Device Identifier: 04035479170356
• UDI-Public: (01)04035479170356(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: 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): 08/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/01/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Unknown