MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S 60; ICD LEAD

Model Number	402265
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Noise on various recordings rv lead and farfield signal leading to vf detections.One shock was delivered but this recording was not transmitted to home monitoring and 2 shocks aborted.Nurse reported that these events correlated with 2 procedures on (b)(6) 2026 and (b)(6) 2026.Advised bringing patient in for follow up as threshold has risen slightly and to view vf recording with shock to determine if arrythmia or noise.Lead currently remains implanted.Should additional information be received this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: PLEXA PROMRI S 60
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 25451144
• Report Number: 1028232-2026-02803
• Device Sequence Number: 18754454
• Product Code: NVY
• UDI-Device Identifier: 04035479140014
• UDI-Public: (01)04035479140014(17)241031
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 402265
• Device Catalogue Number: 402265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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: 54 YR
• Patient Sex: Female