MAUDE Adverse Event Report: Biotronik SE & Co. KG Plexa ProMRI S 65; ICD lead

Model Number	402266
Medical Device Problem Codes	Fracture (1260); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: Plexa ProMRI S 65
• Common Device Name: ICD lead
• Manufacturer (Section D): Biotronik SE & Co. KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; +1(877)245-9800
• MDR Report Key: 50932650
• Report Number: 1028232-2026-04521
• Device Sequence Number: 18541220
• Product Code: NVY
• UDI-Device Identifier: 04035479140021
• UDI-Public: (01)04035479140021(17)220831
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 08/31/2022
• Device Model Number: 402266
• Device Catalogue Number: 402266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Male