MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD

Model Number	370945
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.54 months, oversensing on the ventricular and farfield channel was reported.
Additional Manufacturer Narrative
The icd and the leads under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned data.The manufacturing processes for the leads and the icd were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.The analysis of the available iegms confirmed the presence of noise in the ra and ff channels as well as partially in the rv channel during episode 89.Besides that, the data showed no anomalies.Based on the available data the root cause of the noise could not be determined.The presence of external influences cannot be excluded.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12440350
• Report Number: 1028232-2021-05003
• Device Sequence Number: 4739008
• Product Code: NVN
• UDI-Device Identifier: 04035479113940
• UDI-Public: 04035479113940
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 01/31/2019
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1