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

Model Number	399410
Medical Device Problem Codes	Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Rv lead noise, t-wave oversensing, and an acute increase in short rv interval counts beginning april 17, 2026 were reported.Isometric and postural maneuvers were unable to reproduce the noise observed in stored episode recordings.Lead parameters, including sensing, impedance, and capture thresholds, remain stable and within normal limits.There is concern for a possible lead integrity issue.The lead remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.On (b)(6) 2026 the lead was explanted.Additional report of fracture and inappropriate shocks received.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.

• 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: 24971937
• Report Number: 1028232-2026-01981
• Device Sequence Number: 10456094
• Product Code: NVY
• UDI-Device Identifier: 04035479136116
• UDI-Public: (01)04035479136116(17)181130
• 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: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 399410
• Device Catalogue Number: 399410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2016
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female