MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ECURO DR PROMRI; PACEMAKER

Model Number 377365

Device Problems Impedance Problem (2950); High Capture Threshold (3266); No Pacing (3268)

Patient Problem Loss of consciousness (2418)

Event Date 02/22/2023

Event Type  Death  

Event Description

Patient was found unconscious and brought into hospital where it was noted there was no pacemaker rhythm.Resuscitation was attempted but unsuccessful and the patient died.During resuscitation attempts, high thresholds and increased impedances were noted.Patient had undergone an mri 2 weeks prior which is thought to be the cause of the high thresholds and increased impedances.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker and the leads under complaint were not returned for analysis.The analysis is therefore based on the inspection of the returned data, as well as the quality documents associated with the manufacture of the pacemaker and the leads.The manufacturing processes for these devices were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing.The final acceptance tests proved the devices functions to be as specified.The returned data were evaluated.The follow-up data from (b)(6) 2023 at 15:38 h confirmed a high ventricular pacing threshold of 4.4 v / 0.4 ms.During this follow-up the pacing parameters were reprogrammed accordingly to 7.5 v / 0.75 ms.The data further revealed that two high ventricular rate episodes occurred since the previous follow-up on (b)(6) 2023.No further peculiarities were observed during analysis.Based on all available data the pacemaker functioned as expected.There is no indication of a device malfunction.

• Brand Name: ECURO DR PROMRI
• 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: 16492399
• MDR Text Key: 310766770
• Report Number: 1028232-2023-01137
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 377365
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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; Death