MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 60; PACING LEAD

Model Number	370946
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 58 months, it was reported that a lack of stimulation was observed.After switching from bipolar to unipolar sensing, this behavior was no longer observed.The serial number of the involved lead was reported to us afterwards.
Additional Manufacturer Narrative
Combination product: yes.The device was not returned for analysis.The analysis is therefore based on the existing production documents and the returned device data.The manufacturing process of this device was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.The available device data were thoroughly analyzed.The provided memory segment of the pacemaker showed no indications of a device malfunction.However, the iegms of the follow-up data from 12 december 2019 documented crosstalk of the atrial signal in the ventricle.The cause of this could not be determined based on the available device data.The unipolar and bipolar ventricular impedances, measured during the follow-up, showed a difference in the impedance of only 50 to 70 ohm.Because of this, damage to the ventricular lead cannot be ruled out.In summary, the device shows no anomalies in regard to the manufacturing process and the provided device data.Based on the available information, there is no indication of a device malfunction.If additional relevant information should become available, this report will be updated.
Event or Problem Description
After an implantation period of approximately 58 months, it was reported that a lack of stimulation was observed.After switching from bipolar to unipolar sensing, this behavior was no longer observed.The serial number of the involved lead was reported to us afterwards.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 9679422
• Report Number: 1028232-2020-00609
• Device Sequence Number: 14306349
• Product Code: NVN
• UDI-Device Identifier: 04035479113957
• UDI-Public: 04035479113957
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 11/30/2016
• Device Model Number: 370946
• Device Catalogue Number: 370946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2014
• 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
• Patient Sex: Unknown