MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX ST 53; PACING LEAD

Model Number	346366
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
Fractured lead with impedance greater than 2500 ohms was explanted and replaced.Should additional information be received this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.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.
Additional Manufacturer Narrative
Combination product: yes.Upon receipt, the lead under complaint was found cut 56 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment was not returned.An extraction aid was found on the fragment, it is reasonable to assume that the lead was cut during the surgery.The lead tip including the ring electrode were found covered in fibrotic growth.Calcifications are known for causing high pacing impedance.Furthermore, the insulation was found abraded 39.5 and 48.5 cm proximal to the lead tip.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 ingrowth of the lead which may have affected the lead's motion should be taken into consideration.The conductor coil and insulation were found stretched and damaged between 10.5 and 27.5 cm proximal to the lead tip, 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: SELOX ST 53
• Common Device Name: PACING 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: 22077867
• Report Number: 1028232-2025-02547
• Device Sequence Number: 18242116
• Product Code: NVN
• UDI-Device Identifier: 04035479077846
• UDI-Public: (01)04035479077846(17)141130
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• 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,Followup
• Report Date (Section B): 12/03/2025

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: 11/30/2014
• Device Model Number: 346366
• Device Catalogue Number: 346366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 12/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/27/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2012
• 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: 65 YR
• Patient Sex: Female