MAUDE Adverse Event Report: Biotronik SE & Co. KG Linox Smart S DX 65/15; ICD lead

Model Number	365500
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Chest Pain (1776); Shock from Patient Lead(s) (3162)
Date of Event	06/15/2026
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
Patient was taken to ed by ems (b)(6) 2026 due to four inappropriate shocks received.Ed documentation for the (b)(6) 2026 visit provided the following information.Per the included ems notes, pt told them he experienced a shock saturday, (b)(6) 2026 and went to the hospital but did not want to be admitted and left; then three more shocks were experienced starting at 5 am, (b)(6) 2026.Per notes, pt reported chest pain and icd discharge without preceding symptoms; device was interrogated at facility and reported approximately three inappropriate shocks due to oversensing of rv lead.Noise was also noted, with device at eri when previously noted to have 3-6 months remaining battery life during (b)(6) 2026 interrogation (there was a planned device changeout scheduled for known eri two weeks prior to (b)(6) 2026 ed visit but pt had elected to delay the procedure).Per history noted, there was only one previously documented shock in (b)(6) 2017.Notes state that during (b)(6) 2026 ed visit, pt was seen by ep cath lab surgery and a left heart catheterization with lad fractional flow reserve, as well as ekgs/cxr were performed, with no culprit lesion seen.The device was deactivated and the ep team recommended system extraction and replacement but pt elected to defer intervention and was discharged same day.A subsequent event on or around (b)(6) 2026 was also reported where the icd was explanted and the lead was capped, with no replacement.Should additional information be received, this file will be updated.

• Brand Name: Linox Smart S DX 65/15
• 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 ; +1(877)245-9800
• MDR Report Key: 50531396
• Report Number: 1028232-2026-04032
• Device Sequence Number: 6040542
• Product Code: NVY
• UDI-Device Identifier: 04035479110017
• UDI-Public: (01)04035479110017(17)160930
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 09/30/2016
• Device Model Number: 365500
• Device Catalogue Number: 365500
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2014
• 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