MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER

Model Number 407145

Device Problem Difficult to Interrogate (1331)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

Device could not be interrogated.Based on data from analysis, it was decided to report this event.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

Device was explanted on (b)(6) 2023.

Manufacturer Narrative

Device was explanted on (b)(6) 2023.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 on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The returned device data have been analyzed.The analysis revealed that the pacemaker activated the safety backup mode on (b)(6), 2020, at 03:50pm as a result of the detection of invalid memory content.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.Please note that in the safety backup mode, the pacemaker operates with higher current parameters of 4.8 v at 1.0ms which results in a faster discharge of the battery.Due to the higher current parameters in the safety back mode for such a long time the battery is depleted.The last follow-up was in (b)(6) 2019.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: EDORA 8 DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17329627
• MDR Text Key: 319430590
• Report Number: 1028232-2023-03556
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479147648
• UDI-Public: (01)04035479147648(17)210131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

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: 01/31/2021
• Device Model Number: 407145
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 07/31/2023
• Supplement Dates FDA Received: 07/20/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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 Age: 71 YR
• Patient Sex: Male