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 11/30/2021

Event Type  malfunction  

Event Description

The system was implanted on (b)(6) 2018.The icd is in the recall group lqc.Found in battery status eos.The lead plexa promri s65 showed noise.The icd and the lead rv has been replaced.

Manufacturer Narrative

The icd and the lead under complaint were returned for analysis.The icd was interrogated, revealing the eos battery status.The device was implanted for 39 months and 359 charging cycles were recorded in the icds memory.The amount of charge taken from the battery was verified, indicating the eos battery status to be anticipated.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 25 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.In a next step, the eos status was removed with a technical programmer and 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.The shock therapy was not tested due to the depleted status of the battery.The current consumption of the icd was normal.There was no indication of a device malfunction.The quality documents accompanying the manufacturing processes for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the devices functions to be as specified.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 ventricular channel, which led to multiple shock deliveries.However, a thorough analysis of the icd showed no indication of a device malfunction.The eos battery status was anticipated due to the large amount of charging cycles and shock deliveries.The clinical observation resulted from the observed lead damage.There was no indication of a material or manufacturing problem of the icd or the lead.

• 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: 13156693
• MDR Text Key: 283242460
• Report Number: 1028232-2022-00013
• 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: 12/23/2021

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: 08/31/2019
• Device Model Number: 404685
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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