MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INLEXA 3 HF-T DF-1 IS-1 PROMRI; CRT-D

Model Number 404699

Device Problems Failure to Interrogate (1332); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

It was reported that the eri status was noted via homemonitoring.During in office follow-up the device could not be interrogated and was explanted due to eos status approx.37 months after the implantation.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.Therefore, the device was opened, and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.Subsequently the current consumption of the electronic module was verified by direct measurement and proved to be as expected.There was no indication of a malfunction of the electronic module.Battery voltage measurement confirmed a depleted battery, which could be attributed to an increased internal self-depletion within the battery.Please note that this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: INLEXA 3 HF-T DF-1 IS-1 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: 15801733
• MDR Text Key: 303818439
• Report Number: 1028232-2022-05783
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

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: 03/31/2020
• Device Model Number: 404699
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• 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