MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTOVIS DR

Model Number	365461
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.132 months, it was reported that the device shows the eri status.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore only 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.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.The returned device data were inspected.During the inspection the clinical observation could be confirmed, the eri battery status was activated on (b)(6) 2021.Further analysis revealed an unexpected battery behavior, which led to the clinical observation.The root cause for the clinical observation was not determinable based on all data available.For further insights an analysis of the device itself would be essential.Should further relevant information or the device itself become available this investigation will be updated.

• Brand Name: ENTOVIS DR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14029087
• Report Number: 1028232-2022-01752
• Device Sequence Number: 20027638
• Product Code: NVZ
• UDI-Device Identifier: 04035479109776
• UDI-Public: 04035479109776
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 03/31/2012
• Device Model Number: 365461
• Device Catalogue Number: SEE MODEL NO.
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2010
• 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 Sex: Unknown