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

Model Number	359529
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	03/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient experienced episodes of syncope while traveling.During follow up the device was not able to be interrogated.Device was replaced.
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 device were re-investigated and all production steps were performed accordingly.Upon receipt, the pacemaker was subjected to an electrical incoming inspection.During initial interrogation a warning message was displayed on the programmer indicating invalid memory content and the eri battery status.The devices memory was analyzed revealing that the pacemaker switched into the safety backup mode on (b)(6) 2021 at 08:54 am as a result of the detection of invalid memory content.In general, the pacemaker is equipped with the ability to detect and repair invalid memory content.If the invalid memory content cannot be corrected automatically, by design the pacemaker will activate 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.In the safety backup mode, a standard pacing parameter set is used, 4.8v@1.0ms in the ventricle and 4.8v@1.0ms in the atrium, which may result in a higher current consumption than with the individual program.Therefore, the battery may deplete earlier than estimated during the last follow-up.As a result, a reinitialization request will not prompt on the programming device.The pacemaker was opened for further analysis.The visual inspection of the inner assembly showed no anomalies and the battery was found to be depleted but not defective.The electronic module was attached to an external power supply and a re-initialization was properly feasible.Subsequently, the electronic module proved to be fully functional.There was no indication of a device malfunction.In conclusion, the clinical observation resulted from the higher output during the safety backup mode, which led to an earlier depletion of the battery than estimated during the last follow-up.There was no indication of a material or manufacturing problem.

• Brand Name: EVIA DR-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: 14047593
• Report Number: 1028232-2022-01804
• Device Sequence Number: 4775699
• Product Code: NVZ
• UDI-Device Identifier: 04035479101312
• UDI-Public: 04035479101312
• 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: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: 359529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2012
• 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: 69 YR
• Patient Sex: Male