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

Model Number	370946
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lead was explanted approx.65 months after the implantation due to increasing impedance and pacing threshold resulting in an exit block.
Additional Manufacturer Narrative
Upon receipt the lead was found cut 15cm distal to the is-1 connector pin into two segments.A proximal and a distal lead fragment were received for analysis.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the extraction procedure.The analysis showed that the insulation was found abraded through 19cm and 11cm proximal to the lead tip.This damage most likely resulted due to constant friction against another implantable device such as a nearby lead.A thorough subsequent root cause analysis led to the assumption that the lead might had dislodged due to the above mentioned constant friction, resulting into the observed exit block and electrical issues.Diagnostic images clarifying this assumption were not available.Should additional information or diagnostic images become available, the investigation will be updated.Further damages such as cuts into the insulation 37cm proximal to the lead tip, probably resulted from the extraction procedure.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: 12129436
• Report Number: 1028232-2021-03783
• Device Sequence Number: 17250509
• 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: 2015
• 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): 06/30/2021

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: 06/30/2017
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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