MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 HF-T; CRT-P

Model Number 407138

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

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the returned device data.The returned device data were analyzed thoroughly.Data analysis revealed that the pacemaker switched into the safety backup mode on may 01, 2021 as a result of the detection of invalid memory content.In addition, the last follow-up was documented to be on august 06, 2020.By design, the pacemaker performs self-checks and is equipped with the ability to detect and repair invalid memory content.However, in the case of multiple invalid memory areas, the device cannot correct the memory content and switches into the safety backup mode to ensure patient safety.While in this safety program, the pacemaker is capable to deliver anti-bradycardia therapies.To ensure patient safety, the safety backup parameters are chosen in order to cover the widest population of patients, which can lead to a higher current consumption, draining the battery.The eri battery status was activated properly.Upon interrogation a device status error message appears to notify the user.The manufacturing process for this device was re-investigated 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.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The clinical observation resulted from invalid memory content.The root cause for the invalid memory content was not determinable.However, external influences such as strong electromagnetic fields could be taken into consideration.The eri battery status was activated properly.

Event Description

During the interrogation it was reported that the device triggered an error message and shows the eri status.No adverse change in the patients condition.

• Brand Name: EDORA 8 HF-T
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17916684
• MDR Text Key: 325576370
• Report Number: 1028232-2023-05161
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P070008
• 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
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 407138
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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