MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG TILDA R 53 US; LEAD

Model Number	382889
Medical Device Problem Codes	Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova/microport provided the following information: oversensing and noise were reported on this lead.
Additional Manufacturer Narrative
As of today, the medical devices are not available for analysis, therefore the devices them self could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the devices as well as on the provided data.The available iegm episodes showed artifacts and oversensing in the atrial channel.The manufacturing processes for both device were-investigated.All production steps had been performed accordingly.There were no signs of any inconsistency during the manufacturing processes.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.

• Brand Name: TILDA R 53 US
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9489023
• Report Number: 1028232-2019-05633
• Device Sequence Number: 2080621
• Product Code: NVN
• UDI-Device Identifier: 04035479143305
• UDI-Public: 04035479143305
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 01/31/2014
• Device Model Number: 382889
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 06/26/2020
• 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