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

Model Number 404699

Device Problem Battery Problem (2885)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that the device was explanted due to mos status approx.58 months after the implantation.No adverse patient events were reported.Should additional information be received, this file will be update.

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.There was no indication of a material or manufacturing problem.Upon receipt, the icd was interrogated, revealing the battery status mos2 (10 percent).The icd was implanted for 58 months and 19 charging cycles were recorded to the devices memory.Further, the follow-up data was analyzed.During the follow-up on december 21, 2020 the battery status showed mos1 (63 percent).Therefore, the mentioned battery discharge within 3 months is not comprehensible.The inspection of the device memory revealed that an elevated current was used for anti-bradycardia pacing.This indicates that high output was programmed that resulted in a faster battery discharge.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.

• 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: 16853972
• MDR Text Key: 314399449
• Report Number: 1028232-2023-02192
• 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: 07/27/2023

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: 12/31/2018
• Device Model Number: 404699
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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