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

Model Number	370945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.61 months after implantation, the rv (linox smart) and ra (safio) leads were explanted.Insulation damage was observed.
Additional Manufacturer Narrative
The returned lead was only available in fragments.It had been cut through 12 cm proximal of the tip electrode.The distal lead fragment with an extraction aid were returned for analysis.The proximal lead fragment with the is-1 connector was missing and not available for analysis.The returned fragment was visually inspected.The analysis found multiple signs of abrasion along the lead body.In addition, it turned out that the inner conductor helix was kinked between the tip electrode and the ring electrode, and a cut was detected in the insulation (7 cm proximal of the tip electrode) with a deformed outer conductor helix.This is probably a result of the extraction process.The manufacturing process of the lead was 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: 10311861
• Report Number: 1028232-2020-03039
• Device Sequence Number: 19637710
• 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): 07/08/2020

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: 01/31/2017
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement 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
• Outcome Attributed to Adverse Event: Hospitalization