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	Skin Inflammation/ Irritation (4545)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
System was removed due to skin irritation.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
A skin irritation 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.Additionally 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 skin irritation was not device related.

• 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: 17491659
• Report Number: 3027063190-2023-00008
• Device Sequence Number: 17955273
• Product Code: LGW
• UDI-Device Identifier: 04035479170356
• UDI-Public: (01)04035479170356(17)240229
• 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): 04/03/2024

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: 02/29/2024
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 04/03/2024
• 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: 38 YR
• Patient Sex: Unknown