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

Model Number	370946
Medical Device Problem Code	Pacing Intermittently (1443)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this lead was explanted and replaced due to pacing inhibition.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 24cm and 55cm proximal to the lead tip.The distal and medial fragments were returned for analysis.The proximal fragment including the is-1 connector pin was not returned.An extraction aid was found in the lead body.It is reasonable to assume that the lead was cut during the extraction procedure.The performance of the lead fragments was scrutinized, including a visual inspection.The analysis revealed 35cm proximal to the lead tip that the insulation was found abraded through, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of the damage, it is reasonable to assume that the lead was subject to severe mechanical stress due to constant friction against another implantable device such as a nearby lead.Diagnostic images clarifying this assumption were not available.Further damages such as a ruptured ring electrode from the lead body and a deformed insulation 50 cm proximal to the lead tip, most likely occurred during the extraction procedure due to mechanical forces.The manufacturing process for this device 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: 11205436
• Report Number: 1028232-2021-00371
• Device Sequence Number: 14397944
• 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: 2014
• 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): 01/15/2021

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: 06/30/2016
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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