MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 5 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 404685

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

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

Event Date 01/08/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.48 months, it was reported that the device shows the eos status due to oversensing with inappropriate therapies from the rv lead.The icd was explanted and the lead was capped.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.

Manufacturer Narrative

The lead under complaint was not returned for analysis.This report is therefore only based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacture of the lead and the icd.The manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices functions to be as specified.Upon receipt, the icd was interrogated, revealing the eos battery status, 133 charging cycles were recorded in 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 partially resulted in shock deliveries.Therefore, a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.The analysis of the shock holter data showed that an amount of 128 charging cycles were performed by the device between january 08, 2022 at 05:22 pm and january 08, 2022 at 06:55 pm.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 mos2 battery status.The amount of charge taken from the battery was verified, revealing the mos2 battery status to be as expected.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 was extensively analyzed.In the available iegms the occurrence of noise was observed in the right ventricular channel.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast-successive charging.However, a thorough analysis of the icd proved the device to be fully functional.The integrity of the lead cannot be assured.There was no indication of an icd malfunction.

• Brand Name: INTICA 5 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: 13359895
• MDR Text Key: 284520457
• Report Number: 1028232-2022-00449
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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: 03/31/2019
• Device Model Number: 404685
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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