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

Model Number	346366
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Intermittent loss of capture on telemetry with high outputs programmed on the rv channel were reported.Patient was seen in the er on (b)(6) 2022 due to syncope and the output was increased to 3.5v at 1.5 ms at that time.Impedance and sensing trends were unremarkable.Lead to be evaluated further and remains implanted.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
On (b)(6) 2023 lead was capped.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Combination product: yes.(b)(6) 2023 lead was capped.Upon receipt, the lead under complaint was found cut 29 cm distal to the is-1 connector pin.The proximal and medial fragments were received for analysis.The distal fragment was not returned for analysis.It is reasonable to assume that the lead was cut during the surgery.The returned lead fragments were analyzed.The insulation of the is-1 connector was found damaged 3.5 cm distal to the connector pin.The damage probably occurred during the extraction procedure when removing the lead from the header due to tensile stress.Further analysis of the returned lead fragments did not reveal any irregularity that might have contributed to the reported clinical observations.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: 15180783
• Report Number: 1028232-2022-03959
• Device Sequence Number: 5809129
• Product Code: NVN
• UDI-Device Identifier: 04035479077846
• UDI-Public: 04035479077846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 01/05/2023; 01/16/2025
• Initial Report FDA Received Date: 08/07/2022
• Supplement Report FDA Received Date: 08/11/2022; 01/09/2023; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2009
• 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: 78 YR
• Patient Sex: Male