MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INLEXA 3 HF-T QP DF4 IS4; CRT-D

Model Number 416038

Device Problem Pacemaker Found in Back-Up Mode (1440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

This device went into backup mode and could not be reinitialized.

Manufacturer Narrative

The icd was returned for analysis.The production process for this device was checked.The production documents did not show any irregularities.All production steps were correctly executed.A standard electrical outgoing goods test was performed and good working order was documented.Next, the device status was interrogated.Device status was bos and six charging procedures had been recorded.As described in the complaint, the icd was in safety (rom/backup) mode, as it was upon receipt.Generally speaking, the safety program is loaded from a read-only additional memory.As a result, the anti-bradycardia and anti-tachycardia parameters are pre-set in the safety program, and it is designed to ensure a level of safety that would cover the greatest possible portion of the patient population.The icd memory was examined.The investigation showed that the icd detected inconsistent memory content and, as a result, had automatically activated the safety (rom/backup) program on (b)(6) 2018.The device is generally able to self-correct individual memory sectors.If multiple memory sectors are affected at once, automatic correction is no longer possible and the device will respond as per specifications by switching to the safety mode to ensure patient safety.As per the clinical observation, the icd remained in the safety mode following re-initialization.To determine the root cause of this behavior, the icd was subjected to destructive analysis.The electronics module was sent to the manufacturer for an extensive components analysis.No visual irregularities were apparent.Following an extensive analysis of the individual components, the root cause for the clinical observation could be identified.Damage to the integrated circuit triggered the memory sectors in question.In summary, it can be assumed that the safety mode was activated due to the damaged integrated circuit.It can be assumed that the root cause of the clinical observation occurred after the device had been shipped.

• Brand Name: INLEXA 3 HF-T QP DF4 IS4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8161046
• MDR Text Key: 130253977
• Report Number: 1028232-2018-04318
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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 Model Number: 416038
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 03/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization