MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S DX 65/17; ICD LEAD

Model Number	365501
Medical Device Problem Codes	Fracture (1260); Ambient Noise Problem (2877); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes,.
Event or Problem Description
Hmsc reported shock impedance out of range on 5-feb-2026, the day after a generator changeout.Recordings shows noise on atrial channel of lead.Lead to be evaluated further and currently remains implanted.Should additional information be received this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.The lead was explanted on (b)(6) 2026 and additional report of fracture 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.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: LINOX SMART S DX 65/17
• 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: 24274000
• Report Number: 1028232-2026-00625
• Device Sequence Number: 13267288
• Product Code: NVY
• UDI-Device Identifier: 04035479110024
• UDI-Public: (01)04035479110024(17)151031
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 365501
• Device Catalogue Number: 365501
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 02/24/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/10/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2013
• 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 Age: 37 YR
• Patient Sex: Male