MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 60/16; ICD LEAD

Model Number	359065
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
Lead remains implanted.Potential noise on rv lead in far field and rv channels.Patient will be brought in for history and full lead evaluation to rule out lead integrity vs external emi induced noise.Doctor may have nicked the lead upon implant.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Removed the implant date.The lead was implanted outside of the us and the date is unknown.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Combination product: yes.Removed the implant date.The lead was implanted outside of the us and the date is unknown.(b)(6) 2025 lead was explanted (b)(6) 2025.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
Lead remains implanted.Potential noise on rv lead in far field and rv channels.Patient will be brought in for history and full lead evaluation to rule out lead integrity vs external emi induced noise.Doctor may have nicked the lead upon implant.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Combination product: yes removed the implant date.The lead was implanted outside of the us and the date is unknown.(b)(6) 2025 lead was explanted (b)(6) 2025.Upon receipt, the lead under complaint was found cut 15 cm distal to the is-1 connector pin (into 2 segments).An extraction aid was found on the distal fragment; it is reasonable to assume that the lead was cut during the surgery.The insulation found rubbed through 35.5 cm proximal to the lead tip.Based on the characteristics of the damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant ingrowth of the lead which may have affected the lead's motion should be taken into consideration.Furthermore, the rv shock coil was found deformed, which probably occurred during 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.
Event or Problem Description
Lead remains implanted.Potential noise on rv lead in far field and rv channels.Patient will be brought in for history and full lead evaluation to rule out lead integrity vs external emi induced noise.Doctor may have nicked the lead upon implant.No adverse patient events reported.Should additional information become available, it will be added to this file.

• Brand Name: LINOX SMART SD 60/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12871809
• Report Number: 1028232-2021-06438
• Device Sequence Number: 5941976
• Product Code: NVY
• UDI-Device Identifier: 04035479100384
• UDI-Public: 04035479100384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2025

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 Model Number: 359065
• Device Catalogue Number: 359065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 07/08/2025; 10/30/2025
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/06/2021; 07/22/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 53 YR
• Patient Sex: Unknown