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

Model Number 404621

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

This device was explanted (b)(6) 2023 when rv lead was replaced due to oversensing and inappropriate shocks.Icd was eos on (b)(6) 2023, pt was hospitalized.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for 66 months and 108 charging cycles were recorded in the icds memory.The memory content of the device was inspected.The inspection revealed multiple episodes of regular vt detection on january 27, 2023 and january 28, 2023 due to intrinsic signals.Further, during the analysis of the available iegms, noise was observed in the right ventricular and left ventricular channel of episode 1710.The analysis of the shock holter data showed that multiple charging cycles were performed by the device on january 27, 2023 and january 28, 2023.As a result of that fast-successive charging the eos battery status had occurred.The eos status was removed with a technical programmer and subsequent interrogation revealed the eri battery status.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 addition, 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.In conclusion, the memory content as well as the therapeutic functionality of the icd was extensively analyzed.The activation of the eos status resulted from that fast successive charging.A thorough analysis of the icd, however, proved the device to be fully functional.There was no indication of a device malfunction.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: 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: 16770949
• MDR Text Key: 313596974
• Report Number: 1028232-2023-02015
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male