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

Model Number	370946
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Codes	Dizziness (2194); Syncope/Fainting (4411)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the lead was extracted due to increased threshold and exit block detection approx.24 months after the implantation.Patient experienced dizziness and loss of consciousness.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual and electrical inspection.The visual inspection revealed that the distal part of the lead was partly pulled out of the ring electrode.Based on the characteristics of the damage it is reasonable to assume that the observed damage resulted from tensile forces applied during the extraction procedure.Additionally, cuts into the insulation were found 19cm distal to the is1 connector pin, which most likely resulted from the surgery.However, a thorough analysis of the lead did not show any deviations which might have led to the reported clinical observations.The values of the parameters measured during the electrical analysis were within the technical specifications.The manufacturing process for this device was reinvestigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11980198
• Report Number: 1028232-2021-03155
• Device Sequence Number: 4268871
• Product Code: NVN
• UDI-Device Identifier: 04035479113957
• UDI-Public: 04035479113957
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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