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

Model Number	394931
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to device malfunction involving an inability to sense patient motion properly.No adverse patient events reported.Should additional information become available, it will be added to this file.
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 reinvestigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the device was interrogated properly, and the memory content of the pacemaker was inspected, showing a normal device function while implanted and in service.The battery status was greater than 55%.The pacemaker was programmed to ddd-cls mode with very sensitive sensor settings (sensor gain ¿very high¿, sensor threshold ¿very low¿).Home monitoring data were evaluated showing no anomalies, particularly, regarding the patient´s activity.The pacemaker was subjected to an electrical analysis.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 addition, the device´s accelerator was intensively tested.The heart rate adaptation was proved to be fully functional.In conclusion, the device proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of a device malfunction.
Event or Problem Description
Device explanted due to device malfunction involving an inability to sense patient motion properly.No adverse patient events reported.Should additional information become available, it will be added to this file.

• Brand Name: ETRINSA 8 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: 13078992
• Report Number: 1028232-2021-06933
• Device Sequence Number: 6009960
• Product Code: NVZ
• UDI-Device Identifier: 04035479131821
• UDI-Public: (01)04035479131821(17)180228
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 02/28/2018
• Device Model Number: 394931
• Device Catalogue Number: 394931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2016
• 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: 44 YR
• Patient Sex: Female