MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART T 65; ICD LEAD

Model Number	369820
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.61 months after the implantation, this lead was explanted due to increased pacing thresholds and out of range impedance values (greater than 3000 ohms).
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 available test records confirmed a gradually increase of the pacing impedance trend curve from 1900 ohms to 3000 ohms between (b)(6) 2019 and (b)(6) 2019.Furthermore the available data showed a gradually increase of the pacing threshold from 1.5v to 4.4v between (b)(6) 2019 and (b)(6) 2019 with no further recordings thereafter.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: LINOX SMART T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9318338
• Report Number: 1028232-2019-05001
• Device Sequence Number: 2360792
• Product Code: NVY
• UDI-Device Identifier: 04035479112998
• UDI-Public: 04035479112998
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 04/02/2019

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: 02/29/2016
• Device Model Number: 369820
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 03/06/2020
• 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