MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTICOS 4 DR; PACEMAKER

Model Number 407155

Device Problem No Pacing (3268)

Patient Problem Cardiac Arrest (1762)

Event Date 08/17/2022

Event Type  Injury  

Event Description

Pacemaker was explanted due to failure to pace.Patient suffered cardiac arrest at home and was admitted to the hospital.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device 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 this device 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.The returned device data were inspected, particularly the ram dump data.No anomalies were noted.For further insights available ecgs or the device itself would be essential.Should additional relevant information or the device itself become available, the investigation will be updated.

• Brand Name: ENTICOS 4 DR
• 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: 15815272
• MDR Text Key: 303823259
• Report Number: 1028232-2022-05853
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 407155
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• 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
• Patient Outcome(s): Hospitalization