MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI SD 65/18; ICD LEAD

Model Number	402263
Medical Device Problem Codes	Ambient Noise Problem (2877); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient has noise on near field of rv lead.Hm reports numerous fast nst recordings.Device therapy was turned off on (b)(6) 2025.Lead remains implanted at this time.Should additional information be received this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: PLEXA PROMRI SD 65/18
• Common Device Name: 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: 23518545
• Report Number: 1028232-2025-05504
• Device Sequence Number: 21258783
• Product Code: NVY
• UDI-Device Identifier: 04035479139995
• UDI-Public: (01)04035479139995(17)210331
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Expiration Date: 03/31/2021
• Device Model Number: 402263
• Device Catalogue Number: 402263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female