MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG TILDA R 45 US; PACING LEADS

Model Number	382884
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
Livanova/microport provided the following information: recent device check indicated evidence of doubling of the rv paced sense impedance as well as high voltage lead impedance with no apparent noise sensing.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.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.The provided data covered the period between (b)(6) 2019 and (b)(6) 2019.The records showed a sudden drop of sensing amplitude from 6.1mv to 0.6mv in the middle of (b)(6).The value remained between 0.4mv and 2.5mv until the end of the recorded period.The pacing impedance trend curve showed values between 750ohms and 800ohms until the middle of (b)(6).Then the value disappeared in the provided recordings.The available iegm freezes showed synchronous noise signals on the atrial and ventricular lead.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.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: TILDA R 45 US
• Common Device Name: PACING LEADS
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9117775
• Report Number: 1028232-2019-04210
• Device Sequence Number: 1912962
• Product Code: NVN
• UDI-Device Identifier: 04035479143299
• UDI-Public: 04035479143299
• Combination Product (Y/N): N
• PMA/510(K) Number: P980037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 06/30/2014
• Device Model Number: 382884
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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