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

Model Number 407147

Device Problems Intermittent Capture (1080); Pacing Intermittently (1443)

Patient Problem Syncope/Fainting (4411)

Event Date 06/24/2023

Event Type  malfunction  

Event Description

Patient admitted to hospital with syncope.12 lead ecg showed pauses.Then pacemaker was interrogated.It was noted that there was no high output/backup pacing with loss of capture on ventricular lead with capture control on.Capture control in ventricle was switched off, with fixed 3v at 1.0ms output.Patient is requested to return in 1 month for further analysis.Patient was monitored for 1 hour and then discharged.Device remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker was not returned for analysis.The analysis is therefore 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 pacemaker 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.Available device data have been thoroughly analyzed, in particular the ecg of (b)(6) 2023, at 03:33 pm which documented ineffective right ventricular stimulation without backup stimulation.Based on all data available for analysis the exact root cause for the clinical observation could not be conclusively determined.However, it cannot be excluded that the clinical observation resulted from polarization artifacts of the ventricular lead.It was reported that the pacemaker was reprogrammed to capture control off with a fixed ventricular amplitude of 3.0 v at 1.0 ms.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The available data revealed that polarization artifacts from the ventricular lead most likely led to the clinical observation.

• Brand Name: ENITRA 8 DR-T
• Type of Device: 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: 17273162
• MDR Text Key: 318598264
• Report Number: 1028232-2023-03296
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• 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: 06/30/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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