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

Model Number	382872
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Complete Heart Block (2627)
Date of Event	06/16/2020
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: the patient is an (b)(6)-year-old gentleman, who has a history of chronic atrial fibrillation, complete heart block and a dual-chamber pacemaker in place.He is pacemaker dependent and has shown evidence of fracture on his rv lead with lead impedance greater than 3000 ohms and evidence of noise leading to inhibition of the pacing.His current device switches to unipolar with the increased impedance as a result.Our plan is to place a temporary wire followed by a new rv lead placement and replacement of pulse generator.

• Brand Name: TILDA T 53 US
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 10224945
• Report Number: 1028232-2020-02684
• Device Sequence Number: 2121173
• Product Code: NVN
• UDI-Device Identifier: 04035479143343
• UDI-Public: 04035479143343
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 07/31/2016
• Device Model Number: 382872
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 07/02/2020
• 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