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

Model Number 436909

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that the shock impedance is intermittently >150 ohm.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 recorded a stable rv pacing impedance of 500 ohms and a stable lv pacing impedance of 200 ohms.Furthermore, a fluctuating shock impedance between 130 ohms and >150 ohms was recorded.No iegm episodes were available for analysis.The integrity of the rv lead cannot be assured.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: 19061556
• MDR Text Key: 339884371
• Report Number: 1028232-2024-01933
• 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: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 436909
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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