MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number	404621
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
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 become available, this file will be updated.
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.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status eri.The icd was implanted for 58 months and 91 charging cycles were recorded to the devices memory.The memory content of the device was inspected.During the analysis of the available iegms noise was observed in the right ventricular channel, leading to multiple charging cycles that resulted in several shock deliveries.Therefore a sensing test was performed and the device sensed the applied heart signals free of noise, proving the sensing function of the icd to be normal and as expected.There was no indication of a device malfunction.In a next step, the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.The battery status was anticipated.There was no indication of a device malfunction.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16375567
• Report Number: 1028232-2023-00811
• Device Sequence Number: 20675130
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: (01)04035479142087(17)190531
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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: 05/31/2019
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/15/2023; 08/07/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/15/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2017
• 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: 86 YR
• Patient Sex: Male