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

Model Number 407155

Device Problem High Capture Threshold (3266)

Patient Problem Cardiac Arrest (1762)

Event Date 08/05/2022

Event Type  Death  

Event Description

The patient was implanted with an enticos 4 dr pacemaker at (b)(6) hospital affiliated to (b)(6) university school of medicine on (b)(6) 2022, with good intraoperative parameters.Three months after surgery ((b)(6) 2022), the parameters were still normal and the ventricular threshold was 0.7v@0.4ms.On (b)(6) 2022, the patient went into cardiac arrest while being transferred to a local hospital.During cpr, the doctor found that the patients pacemaker had stopped working.The doctor of (b)(6) hospital contacted biotronik tsr to program the patient device.During the program, we found that the ventricular threshold of the patient raised to 3.4v@0.5ms, and immediately adjusted the ventricular output voltage to 4.8v@1.0ms.The patient died on (b)(6) 2022.

Manufacturer Narrative

The devices under complaint were not returned for analysis.The analysis is therefore based on the returned data, as well as the inspection of the quality documents associated with the manufacture of the leads and the pacemaker.The manufacturing processes for the leads and the pacemaker were 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 final acceptance tests proved the devices functions to be as specified.The returned data were inspected.The data documented that at follow-up on (b)(6) 2022 the rv pacing values were 2.4 v / 0.4 ms.The last measured rv pacing threshold was 0.7 v on (b)(6) 2022.The threshold value of 0.7 v was confirmed during the follow-up through a manual threshold test.At the time of the next follow-up on (b)(6) 2022, the rv pacing values were 3.6 v / 0.4 ms, automatically set by the pacemaker, with the warning threshold not found.Automatic capture control had set the rv pacing amplitude to the value (starting value of 2.4 v + safety margin of 1.2 v = 3.6 v).During the follow-up a manual threshold test was performed, which measured a very high rv pacing threshold of 3.4 v / 0.5 ms.At the end of the follow-up the rv pacing values were set manually to 4.8 v / 1.0 ms and automatic capture control was also manually deactivated.The pacemaker was working properly based on the data.The pacing impedance values in the rv were normal.No anomalies were noted.It was reported that the patient passed away on (b)(6) 2022, the day after the last follow up.Based on all information available for analysis, the root cause of the patients death was not determinable.However, no direct relationship was found between the patients death and the devices under investigation.Analysis showed no indication of a malfunction.

• Brand Name: ENTICOS 4 DR
• 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: 15298047
• MDR Text Key: 298652468
• Report Number: 1028232-2022-04347
• 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: 08/19/2022

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: 03/31/2023
• Device Model Number: 407155
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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): Death