MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SIELLO T 60; PACING LEAD

Model Number	362706
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
It was reported the patient had a very high and fluctuating ventricular threshold upon new lead insertion.The lead was repositioned with no success and finally it was explanted three days after the implantation.A new lead with active fixation was implanted.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The analysis revealed a cut into the insulation (approx.26 cm distal to the is-1 connector pin), which most likely resulted from the explantation procedure.A thorough analysis of the lead did not show any deviations which might have led to the reported observation.In particular the values measured during the electrical analysis were within the specifications.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: SIELLO T 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9593259
• Report Number: 1028232-2020-00219
• Device Sequence Number: 16955227
• Product Code: NVN
• UDI-Device Identifier: 04035479106263
• UDI-Public: 04035479106263
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 08/31/2021
• Device Model Number: 362706
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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