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

Model Number 407146

Device Problems Impedance Problem (2950); No Pacing (3268)

Patient Problem Syncope/Fainting (4411)

Event Date 11/24/2022

Event Type  malfunction  

Event Description

Patient taken to er due to loss of consciousness where v pacing failure was confirmed.Device was explanted due to pacing failure and impedance issue.Should additional information be received, this file will be updated.

Manufacturer Narrative

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 revealing the battery status ok.The devices memory content was evaluated.No anomalies were noted.Evaluation of provided follow-up data from november 24 / 25, 2022 documented loss of capture in the atrial as well as in the ventricular channel.Manually triggered impedance measurements were unsuccessful.Inspection of home monitoring data revealed a decrease of the current consumption since november 14, 2022 indicating a missing pacing functionality.Thus, the pacemaker was subjected to an extensive electrical analysis and the ability of the device to deliver therapies was verified.Thereby the clinical observation was confirmed, the pacing capability was not available.The impedance measurement test was unsuccessful, only old impedance measurement values were displayed on the programmer.During the further course of the analysis, the pacemaker was reset manually to potentially resume the pacing functionality and the device was re-tested.After reset the pacemaker was fully capable to deliver appropriate anti-bradycardia therapy.Furthermore, a review of the memory content did not show any peculiarities.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.No intermittent or permanent loss of output was present.A stress test under different temperature environments was performed.The pacemaker functionality was as expected.In conclusion, the clinical observation was confirmed, however, the root cause was not determinable.In particular, after a manually triggered pacemaker reset the device proved to be fully functional.Based on the device behavior during analysis, a component damage of the pacemaker does not seem likely.Instead, external influences, like strong electromagnetic fields, could have possibly contributed to this event.

• Brand Name: EVITY 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: 15877088
• MDR Text Key: 304449954
• Report Number: 1028232-2022-06010
• 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: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 407146
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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 Outcome(s): Hospitalization