MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 6 DR-T; PACEMAKER

Model Number	407149
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.19 months, it was reported that the device could not be interrogated by two (2) different programmers.The pacemaker 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 pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was subjected to an electrical incoming inspection.Neither an interrogation nor any anti-bradycardia pacing signals were present, confirming the clinical observation.Therefore, the pacemaker was opened and subjected to further analysis.The visual inspection of the inner assembly showed no anomalies, but the battery was found to be depleted.The battery was disconnected from the electronic module.Using an external power supply, further thorough investigation of the electronic module did not show any anomalies.All therapy functions were available and worked as expected.The current consumption was directly measured and proved to be normal and expected.In addition, a long-term storage test of the electronic module was performed, and the device functionality was continuously monitored.No anomalies were noted during the test.At a next step the battery was sent to the manufacturer for analysis.The manufacturing process for the battery 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.Subsequently the battery was subjected to a visual and an electrical inspection, including x-ray as well as microcalorimetry analysis and confirmed the battery depletion.However, the destructive analysis did not reveal any abnormality which might have led to an early depletion of the battery.In summary, despite the dedicated analysis, the root cause of the early battery depletion could not be determined.The therapeutic functionality of the device was tested with an attached external power supply and proved to be fully functional.

• Brand Name: EVITY 6 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: 11874309
• Report Number: 1028232-2021-02818
• Device Sequence Number: 1009221
• Product Code: NVZ
• UDI-Device Identifier: 04035479147686
• UDI-Public: 04035479147686
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 12/31/2020
• Device Model Number: 407149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• 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