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

Model Number 407149

Device Problems Failure to Capture (1081); Low Sensing Threshold (2575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

The pacemaker and the leads under complaint were not returned for analysis.The analysis is therefore based on the received data, as well as the inspection of the quality documents associated with the manufacture of these devices.The manufacturing processes for the pacemaker and the leads were reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance tests proved the devices functions to be as specified.The returned data were thoroughly inspected.The inspection confirmed the occurrence of loc on (b)(6) 2023, with a fixed programmed rv pacing amplitude of 2.4 v.Capture control was set to off, as mentioned in the complaint description.During the follow-up on (b)(6) 2023, the rv pacing threshold was measured with a resulting value of 1.1 v.The lead impedance trends show no anomalies.Despite these observations, the returned data show no indication of a pacemaker malfunction.It is reasonable to assume that the clinical observation resulted from fluctuating values of the pacing threshold, presumably related to a potential lead problem.Should further relevant information or the lead itself become available for analysis, this report will be updated.

Event Description

This device was reported to have no ventricular capture and <1.0v threshold and 2.4v output.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.

• Brand Name: EVITY 6 DR-T
• Type of Device: 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: 18506155
• MDR Text Key: 332896446
• Report Number: 1028232-2024-00212
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 407149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1