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	07/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.26 months, oversensing on the ventricular channel was reported.The leads were explanted.
Additional Manufacturer Narrative
Safio s 53 - sn (b)(6).The lead under complaint was subjected to an extensive analysis.The analysis revealed cuts into the insulation (20.5 cm distal to the is-1 connector pin), which most likely resulted during the extraction procedure.A thorough analysis of the lead did not show any deviations which might have led to the reported clinical observation.In particular, the values of the parameters measured during the electrical analysis were within the technical specifications.Safio s 60 - sn (b)(6).The lead under complaint was subjected to an extensive analysis.The visual inspection revealed abrasion marks along the lead body.In particular 21.5 cm distal to the is-1 connector pin, immediately distal to the ligature marks, the insulation was found rubbed through and the inner conductor coil was found fractured, which is assumed to be the root cause of the reported oversensing.Based on the characteristics, as well as the location of the damage, it is reasonable to assume that the lead was subject to excessive mechanical forces distal to the ligature sleeve.Further damages such as cuts into the insulation (20 cm distal to the is-1 connector pin), most likely occurred during the extraction procedure.Sentus promri otw qp l-85 - sn (b)(6).The lead under complaint was subjected to an extensive analysis.The visual inspection revealed abrasion marks along the lead body.In particular 47 cm distal to the is-4 connector pin the lead body was found deformed.In this region the conductor coils were found fractured, which is assumed to be the root cause of the re-ported oversensing.Based on the characteristics, as well as the location of the damage, it is reasonable to assume that the lead was subject to excessive mechanical forces as the result of clavicular first rib entrapment.Further damages such as cuts into the insulation (49 cm distal to the is-4 connector pin), most likely occurred during the extraction procedure.The manufacturing processes for the leads (b)(6) were 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: 10475727
• Report Number: 1028232-2020-03682
• Device Sequence Number: 2536391
• 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: 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): 08/17/2020

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: 12/31/2019
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/30/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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