MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 6 DR-T; PACEMAKER

Model Number	407149
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
At first interrogation the programmer showed that the device was in safe mode.We pressed the re-initialize button and the device switch to normal window but with rf telemetry disabled, so we decided to return the device for further inspection.
Additional Manufacturer Narrative
The pacemaker was received still in the sterile blister.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 subjected to an electrical incoming inspection.The device was properly interrogatable both by using the programming wand as well as by rf telemetry.The pacemaker¿s memory content was inspected.The device´s memory documented several manually triggered resets on (b)(6) 2022.On (b)(6) 2022 the device was successfully re-initialized.Please note, that after re-initialization the rf telemetry is temporarily not available.This does not represent a device malfunction.However, for further insights related to the documented manually triggered reset and the reported activation of the safety backup mode a complete programmer dump would be essential.In general, 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.Upon interrogation a device status error message appears to notify the user.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.There was no indication of a device malfunction.In summary, the device is fully functional.With regard to the issues as mentioned in the complaint description, the analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.
Event or Problem Description
At first interrogation the programmer showed that the device was in safe mode.We pressed the re-initialize button and the device switch to normal window but with rf telemetry disabled, so we decided to return the device for further inspection.

• Brand Name: EVITY 6 DR-T
• Common Device Name: PACEMAKER
• 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: 13794547
• Report Number: 1028232-2022-01346
• Device Sequence Number: 3822609
• Product Code: NVZ
• UDI-Device Identifier: 4035479147686
• UDI-Public: (01)4035479147686(17)220831
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 407149
• Device Catalogue Number: 407149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown