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

Model Number 407145

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.59 months, it was reported that the device went in the eos status after mri.The icd was explanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The returned pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was properly interrogated.The battery status was found to be eri which was activated on (b)(6) 2022, during follow-up.Further detailed analysis on the devices memory revealed that the eri battery status was triggered most likely by a programmed higher current consumption program (e.G.The mri program with d00, 90 bpm, 4.8 v at 1.0 ms) and not due to a depleted battery.In addition, data documented that between (b)(6) 2019 and (b)(6) 2020 the safety backup mode was activated which also results in a faster discharge of the battery due to high current parameter in the safety backup mode.In general, a minimum of 6 months from eri to eos needs to be guaranteed for safety reasons, independent of the programmed parameters.In case of higher output programming a large proportion of battery capacity has to be reserved by the pacemaker, which may result in triggering of eri.This does not represent a device malfunction.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed in eri mode.Next, the eri battery status was successfully reset, and subsequent interrogation yielded the battery status ok.There was no indication of a device malfunction.In conclusion, the device proved to be fully functional.The analysis revealed that the eri battery status was not declared by a premature battery depletion.Instead, it is reasonable to assume that a higher output program led the device to switch into the battery status eri.There was no indication of a material or manufacturing problem.

• 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: 16383958
• MDR Text Key: 309643766
• Report Number: 1028232-2023-00842
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• 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,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 407145
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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