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

Model Number	370946
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today, the medical devices were not available for analysis, therefore the devices them self could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the devices as well as on the provided data.The manufacturing processes for both device were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The analysis of the provided follow up data, recorded between june 16th, 2020 and october 20th, 2020, showed the rv sensing amplitude fluctuating between 12 and 14 mv with intermittent measurements.The rv pacing impedance was initially recorded fluctuating around 500 ohm.After the switch to unipolar on (b)(6) 2020, the impedance was further recorded at approximately 330 ohm till the end of the recorded period.In the provided iegm episodes, artefacts were found in the rv and atrial channel, which led to the reported oversensing.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the leads them self would be necessary to determine the root cause.Should additional information or the devices them self become available for analysis, the investigation will be updated.
Event or Problem Description
It was reported that approx.88 months after the implantation a lead failure alert was received via home monitoring.The patient was called in the clinic for a check.This right ventricular lead switched to unipolar.Furthermore the impedance fluctuation was noted and oversensing on the atrial channel.Lead replacement is being considered.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 10880191
• Report Number: 1028232-2020-05099
• Device Sequence Number: 11762589
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 12/31/2014
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1