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

Model Number	402263
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Ambient Noise Problem (2877)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
This lead shows noise which led to inappropriate shocks.Lead remains implanted.Should additional information become available, 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.
Additional Manufacturer Narrative
Combination product: yes.04-feb-2026 update: the lead was explanted and additional report of low impedance was received.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.
Additional Manufacturer Narrative
Combination product: yes.On (b)(6) 2026 update: the lead was explanted and additional report of low impedance was received.Upon receipt, the lead under complaint was found cut 10.5 cm distal to the df4 connector pin (into 2 segments).All fragments were received for analysis.An extraction aid was found on the distal fragment; it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the insulation was found rubbed through 55.5 and 57.5 cm distal to the df4 connector pin, which is assumed to be the root cause of the reported clinical observations.Based on the characteristics of the insulation damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.Furthermore, the rv shock coil was found deformed, which most likely resulted from the extraction procedure due to tensile stress.Prior to the analysis of the device, 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.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• 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: 23413161
• Report Number: 1028232-2025-05276
• Device Sequence Number: 9085077
• Product Code: NVY
• UDI-Device Identifier: 04035479139995
• UDI-Public: (01)04035479139995(17)210131
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2026

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: 01/31/2021
• Device Model Number: 402263
• Device Catalogue Number: 402263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 02/04/2026; 05/05/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/05/2025; 02/04/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male