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	Unspecified Infection (1930)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During normal lead pull, doctor mentioned the patient having a superficial infection and sent her home with antibiotics.The patient returned to the clinic complaining of increased headaches and backaches.Doctor referred her to the hospital where she was admitted for an infection that could potentially have occurred from her recent scs trial.The physician also stated that the patient received a ct scan with the following information: linear 5.8mm bone attenuating foci t12/l1 potential foreign body.The leads did not show any damage when removed so it is doubtful the foreign body is from them.
Additional Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additional an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In summary, the infection was not device related.

• Brand Name: RESILIENCE 55TR
• 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: 22069758
• Report Number: 3027063190-2025-00088
• Device Sequence Number: 18482438
• Product Code: LGW
• UDI-Device Identifier: 04035479170356
• UDI-Public: (01)04035479170356(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P210037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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
• Device Model Number: 457850
• Device Catalogue Number: 457850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2025
• 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
• Patient Age: 60 YR
• Patient Sex: Unknown