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

Model Number 404630

Device Problems Premature End-of-Life Indicator (1480); Charging Problem (2892)

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

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Device is exhibiting unexpected charging time behavior.No adverse patient events were reported.Device currently remains implanted and will be evaluated further.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was received for analysis.Explant date is currently unknown.It was reported that the device went from eri to eos in two days.The icd was initially complained in november 2019.Data analysis was performed, and the analysis results, indicating a defective component, were communicated in november 2019.It was reported that on may 2023 the icd reached the eos status, upon which the icd was explanted and returned to biotronik for analysis, 3.5 years after providing the data analysis results.Upon receipt, the device interrogation revealed the eos battery status, detected on may 20th, 2023, confirming the clinical observation.The device was subjected to an electrical analysis.During the analysis the battery was found depleted.The current consumption of the icd was measured and proved to be normal and as expected.Therefore, the icd was opened to inspect the inner assembly and to check the functionality of the electronic module.Visually no deficiencies were observed.The current consumption of the electrical module was directly measured and found to be elevated.In a next step, the electrical module was attached to an external power supply and the eos status was removed with a technical programmer to verify the ability of the device to deliver therapies.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.Further electrical investigations revealed that a low voltage capacitor of the electronic module was damaged, causing an increased current consumption, draining the battery.The manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, the clinical observation resulted from a damaged low voltage capacitor on the electronic module.There was no sign of any inconsistency during the manufacturing process which may be related to this observation.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: INTICA 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: 16908770
• MDR Text Key: 314980337
• Report Number: 1028232-2023-02366
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 404630
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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