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

Model Number 407147

Device Problem Intermittent Capture (1080)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

An intermittent loss of capture on the ventricular channel was observed.The pacemaker was replaced.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker and the lead under complaint were not available for analysis.The analysis is thus based on the inspection of the quality documents associated with the manufacture of these devices as well as the data available for evaluation.The manufacturing processes for the pacemaker and the lead 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 available data were thoroughly inspected.The reported loss of capture with high rv pacing parameters (4.0 v / 0.4 ms) in bipolar configuration was confirmed.The data from the timeframe in which the pacemaker was programmed to unipolar rv pacing configuration, with 2.4 v / 0.4 ms, show no anomalies.In particular, the impedance trend in unipolar configuration documents normal values.Based on the information available for analysis, the root cause of the clinical observation is not determinable.However, the integrity of the lead may be compromised.There is no indication of a pacemaker malfunction.Should the lead or pacemaker become available for analysis, this investigation will be updated.

• Brand Name: ENITRA 8 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: 17830732
• MDR Text Key: 324444007
• Report Number: 1028232-2023-04848
• 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: 09/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 407147
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 09/28/2023
• Date Device Manufactured: 06/07/2018
• 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
• Patient Outcome(s): Hospitalization