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

Model Number	370946
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.30 months, oversensing on the ventricular channel was reported.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut approx.17 cm distal to the is-1 connector pin.Only the proximal fragment was received for analysis.The distal fragment including the lead tip was not received for analysis.The returned lead fragment was visually and electrically analyzed.The visual inspection showed that the is-1 connector pin was sheard off.In addition, deformations of the inner coil close to the is-1 connector pin were found which most likely were caused by overrotation of the inner coil during the retraction of the fixation helix.Further investigation revealed that the insulation was, apart from the present fragmentation, free of breaches.During the electrical analysis, the dc resistances of the received conductor fragment were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.The manufacturing process for this lead was re-investigated.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: 9306716
• Report Number: 1028232-2019-04923
• Device Sequence Number: 11270309
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: 03/31/2019
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1