MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 VR-T DF4; ICD

Model Number	393041
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to eos.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, showing an eos battery status activated on october 30, 2022, with 242 charging cycles recorded in the devices memory.The device was subjected to electrical analysis, and the eos status was reset with a technical programmer.Subsequent interrogation confirmed the eos battery status.Analysis of available iegms revealed disturbances in the ventricular channel (episodes 129-155).A minimum of 128 inappropriate charging cycles were identified; however, no inappropriate shock deliveries were observed.Hence, the amount of charge taken from the battery was verified and the battery condition was found to be as anticipated.In conclusion, the analysis confirmed activation of the eos battery status on october 30, 2022.The eos battery status was found to be as anticipated based on the amount of charge taken from the battery.The analysis revealed no indication of a device malfunction.

• Brand Name: ITREVIA 7 VR-T DF4
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 19306549
• Report Number: 1028232-2024-02621
• Device Sequence Number: 6598989
• Product Code: LWS
• UDI-Device Identifier: 04035479129569
• UDI-Public: (01)04035479129569(17)180131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 01/31/2018
• Device Model Number: 393041
• Device Catalogue Number: 393041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• 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: 57 YR
• Patient Sex: Female