MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO S 60; ICD LEAD

Model Number	379970
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This rv lead was explanted due to noise.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.Upon receipt, the lead under complaint was found cut 11 cm distal to the df4 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 was found damaged 7, 10, 21 and 28 cm proximal to the lead tip.Additionally, the conductor cable leading to the rv shock coil was found fractured 28 cm proximal to the lead tip.Based on the characteristics of the damages mentioned above, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.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.

• Brand Name: PROTEGO S 60
• 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: 22346906
• Report Number: 1028232-2025-03094
• Device Sequence Number: 8527028
• Product Code: NVY
• UDI-Device Identifier: 04035479121495
• UDI-Public: (01)04035479121495(17)160630
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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
• Device Expiration Date: 06/30/2016
• Device Model Number: 379970
• Device Catalogue Number: 379970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2014
• 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: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Unknown