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

Model Number	371992
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information become available, this report will be updated.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the returned device data, as well as the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly, the final acceptance test proved the device functions to be as specified.The returned device data was analyzed thoroughly.The battery condition was found to be as expected.The eri battery status was properly activated on (b)(6) 2024, based on the data available.After eri activation, the battery voltage temporarily recovered to a value above the eri threshold.This does not represent a battery malfunction but results in a displayed message during interrogation.Should additional relevant information or the device itself become available, the investigation will be updated.
Event or Problem Description
This device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information become available, this report will be updated.

• Brand Name: ENTOVIS DR-T PROMRI
• 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: 20853870
• Report Number: 1028232-2024-06294
• Device Sequence Number: 8785936
• Product Code: NVZ
• UDI-Device Identifier: 04035479115173
• UDI-Public: (01)04035479115173(17)160229
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 02/29/2016
• Device Model Number: 371992
• Device Catalogue Number: 371992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2014
• 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 Age: 88 YR
• Patient Sex: Female