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

Model Number	369818
Medical Device Problem Codes	Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This rv lead was explanted due to noise and oversensing.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.Upon receipt, the lead under complaint was found cut 13.5 cm distal to the is-1 connector pin (into 2 segments).All fragments were received for analysis.An extraction aid was found on the distal fragment.The insulation was found rubbed through approximately 9 cm proximal to the lead tip, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of this 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, inner conductor coil in the distal end region and fixation helix were found stretched.These deformations 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.

• Brand Name: LINOX SMART S 65
• 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: 19471070
• Report Number: 1028232-2024-03053
• Device Sequence Number: 3404475
• Product Code: NVY
• UDI-Device Identifier: 04035479112974
• UDI-Public: (01)04035479112974(17)170731
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 07/31/2017
• Device Model Number: 369818
• Device Catalogue Number: 369818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2015
• 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: 60 YR
• Patient Sex: Female