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

Model Number	370945
Medical Device Problem Codes	Break (1069); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the atrial lead showed insulation damage and coil fracture due to subclavian crush syndrome approx.29 months after implantation.The lead was explanted and replaced.
Additional Manufacturer Narrative
In the returned state, the lead had been cut through 13 cm distal of the is-1 connector pin, and outer conductor helix and insulation were fractured 25.5 cm proximal of the electrode tip.A proximal, a medial, and a distal lead fragment were available for analysis, and a 5 cm long, capped inner conductor helix was also returned.The returned fragments were thoroughly analyzed.The visual analysis of the lead fragments detected that the insulation of the lead body was massively damaged by squashing about 25.5 cm proximal of the electrode tip.The outer conductor helix was fractured at this site.This damage pattern is with high probability to be regarded as the cause of the clinical complaint.Position and characteristics of the damage (squashing of the lead body) lead to the assumption of excessive mechanical stress of the lead due to the subclavian crush syndrome.In addition, the inspection found cuts 30 cm proximal of the electrode tip, deformations of the outer conductor helix 24 cm to 18 cm proximal of the electrode tip, and a stretched fixation, which are probably a result of the extraction procedure.The manufacturing process of this 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: 10171407
• Report Number: 1028232-2020-02476
• Device Sequence Number: 11603381
• 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: 2018
• 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): 05/26/2020

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: 10/31/2019
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 06/18/2020
• 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