MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO SD 65/18; ICD LEAD

Model Number	399410
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
This lead was explanted due to noise, causing inappropriate shocks.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.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.
Additional Manufacturer Narrative
Combination product: yes.Upon receipt, the lead under complaint was found cut 20.5 cm distal to the df4 connector pin into two fragments.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the surgery.The insulation was found rubbed through in the distal end region.Furthermore, the conductor cable was found fractured 8.5 cm proximal to the lead tip.These damages are assumed to be the root cause of the reported oversensing leading to inappropriate shocks delivery.Based on the characteristics of these damages, 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 shock coils were 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.

• Brand Name: PROTEGO SD 65/18
• 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: 22669289
• Report Number: 1028232-2025-03588
• Device Sequence Number: 19789594
• Product Code: NVY
• UDI-Device Identifier: 04035479136116
• UDI-Public: (01)04035479136116(17)160930
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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
• Device Expiration Date: 09/30/2016
• Device Model Number: 399410
• Device Catalogue Number: 399410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 12/08/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/05/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2013
• 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: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female