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

Model Number	394931
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
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.In a next step, the returned device data was inspected.Analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Therefore, and in order to exclude any potential harm for the patient, we would like to recommend replacing the device and returning it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care and the frequency of follow-up sessions.The above recommendation is based on a purely technical assessment.Should the device become available, this investigation will be updated.
Event or Problem Description
This device was explanted due to unexpected battery behavior.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device 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.Particularly the final acceptance test proved the device functions to be as specified.Upon initial interrogation a warning message was triggered regarding the battery condition, confirming the clinical observation.The memory content of the device was inspected.The inspection revealed that the eri battery status was activated on (b)(6) 2022.The battery voltage decreased faster than expected.However, the current consumption was normal.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 eri mode.There was no indication of a device malfunction.During subsequent analysis the device was opened and subjected to further investigation.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage confirmed an almost depleted battery.A thorough investigation of the electronic module did not show any abnormality.In particular, the current consumption was directly measured and proved to be normal and expected.The battery was sent to the manufacturer for further analysis.The battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The measurement of the battery voltage confirmed an almost depleted battery.Microcalorimetry analysis was performed which showed no anomalies.Next, the battery was opened for destructive analysis and the inner assembly was inspected.During analysis no internal electrical short was evident.However, the occurrence of a temporary short circuit that contributed to an increased internal self-depletion cannot be excluded.In summary, the root cause for the premature battery depletion could not be determined conclusively.Based on the analysis all therapy functions of the device were available while the device was implanted and in service.

• Brand Name: ETRINSA 8 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: 15335039
• Report Number: 1028232-2022-04437
• Device Sequence Number: 6861983
• Product Code: NVZ
• UDI-Device Identifier: 04035479131821
• UDI-Public: (01)04035479131821(17)170731
• 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: 2016
• 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): 05/16/2023

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: 07/31/2017
• Device Model Number: 394931
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2016
• 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: 76 YR
• Patient Sex: Female