MAUDE Adverse Event Report: Biotronik SE & Co. KG Sentus ProMRI OTW QP L-85/49; LV lead

Model Number	408719
Medical Device Problem Codes	High impedance (1291); Extracardiac stimulation (1463); High Capture Threshold (3266)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This lead was explanted due to high threshold, high impedance, and diaphragm stim.Should additional information be received this file will be updated.
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.

• Brand Name: Sentus ProMRI OTW QP L-85/49
• Common Device Name: LV lead
• Manufacturer (Section D): Biotronik SE & Co. KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; +1(877)245-9800
• MDR Report Key: 50565559
• Report Number: 1028232-2026-04027
• Device Sequence Number: 13276162
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: (01)04035479148959(17)190831
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

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: 08/31/2019
• Device Model Number: 408719
• Device Catalogue Number: 408719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Male