MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S DX 65/15; ICD LEAD

Model Number 436909

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem Cardiac Perforation (2513)

Event Date 02/09/2024

Event Type  Injury  

Event Description

A drop in the ventricular sensing and impedance trends and no capture at maximum output were found.X-ray revealed a lead perforation.It was decided to treat the patient with a surgical approach.Should additional information be received, this file will be updated.

Manufacturer Narrative

As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.The quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The analysis of the provided trend data, acquired between (b)(6) 2024 and (b)(6) 2024 recorded an initial pacing impedance of 500 ohms with a drop to 300 ohms shortly after and an increase to 700 ohms at the end of recording period.Furthermore, an increasing shock impedance from 55 ohms to 75 ohms was recorded.The analysis of the provided iegm episodes revealed electromagnetic interference artifacts on the atrial, rv and far-field channel and the presence of the far-field on the ra channel, which led to oversensing.The provided x-ray images were analyzed.The perforation of the lead into the pericardium can be confirmed.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: PLEXA PROMRI S DX 65/15
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18707319
• MDR Text Key: 335402931
• Report Number: 1028232-2024-00859
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• PMA/PMN Number: P980023
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 436909
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• 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