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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.32 months, an increasing threshold was observed at the follow-up.During revision physician had difficulties removing the ventricular lead from the header.The pacemaker was explanted and the lead was capped.
Additional Manufacturer Narrative
The lead under complaint was not returned for analysis.This report is therefore only based on the analysis of the pacemaker itself as well as the inspection of the quality documents associated with the manufacture of the lead and the pacemaker.The manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices functions to be as specified.Upon receipt, the pacemaker was interrogated, and the memory content was analyzed.The battery status showed 75 percent.The device data showed an elevated right ventricular lead impedance since (b)(6), 2019.In addition, the device data revealed a right ventricular lead failure, detected on (b)(6), 2019.However, it cannot be excluded that the rv set screw was not tightened properly and therefore led to the clinical observation.The header of the device was visually inspected and analyzed.The visual inspection showed residues of blood in the ventricular header bore.However, the set screws could be easily screwed in and out.All dimensions of the header bores were within the range requested by the standard specifications.Also the spring elements of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.Furthermore, the provided pictures were inspected.Based on the pictures as well as on the results of the analysis of the devices header it can be assumed that the connector pin of the lead was contaminated with blood residues.In conclusion, there was no indication of a pacemaker malfunction.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13657064
• Report Number: 1028232-2022-01073
• Device Sequence Number: 5009402
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 03/31/2021
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown