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

Model Number	407157
Medical Device Problem Codes	No Pacing (3268); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During device changeout, device was programmed voo at 60 and, when the pocket was opened, the device stopped pacing and was in backup-mode.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The 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 visually inspected revealing no anomalies and the device was properly interrogated.The pacemaker's memory content was inspected.The inspection revealed that the device switched into the safety backup mode on (b)(6) 2024, 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 in unipolar lead configuration.Upon interrogation a device status error message appears to notify the user.Please note, that in unipolar configuration sufficient tissue contact is necessary for effective stimulation.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 conclusion, 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, like electric cautery, could be taken into consideration.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: EDORA 8 SR-T
• Common Device Name: 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: 20190090
• Report Number: 1028232-2024-04776
• Device Sequence Number: 15204268
• Product Code: NVZ
• UDI-Device Identifier: 04035479147761
• UDI-Public: (01)04035479147761(17)241130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 11/30/2024
• Device Model Number: 407157
• Device Catalogue Number: 407157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male