MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD

Model Number	370945
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both leads were explanted approx.54 months after implantation.The atrial lead showed oversensing.
Additional Manufacturer Narrative
The linox smart and the safio lead were returned for analysis.Safio s 53.In the returned state, the lead had been cut through 10cm distal of the is-1 connector pin.A proximal and a distal lead fragment were available for analysis.The returned fragments were thoroughly analyzed.The visual inspection found that the insulation of the lead body was frayed 36cm proximal of the tip electrode.This damage is with high probability the cause of the oversensing complained about.The position and kind of the frayings are characteristic for massive mechanical stress of the lead due to strong pressure onto the generator housing with simultaneous friction against it.The manufacturing processes of both leads were reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.In summary, there were no indications of a material defect or manufacturing error.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9941668
• Report Number: 1028232-2020-01650
• Device Sequence Number: 2176620
• Product Code: NVN
• UDI-Device Identifier: 04035479113940
• UDI-Public: 04035479113940
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 05/31/2017
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization