MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/18; ICD LEAD

Model Number	359074
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this lead was fractured with rising impedances since (b)(6) 2020.Lead was explanted and replaced.No adverse patient events were reported.Should additional information become available, this file will be updated.
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.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut approx.25cm proximal to the lead tip.The distal lead fragment and a medial lead fragment were returned for analysis.The proximal lead fragment including the connector was missing.The returned lead fragments were visually and electrically analyzed.The visual inspection revealed multiple abrasion marks along the lead fragments.Both shock coils were covered from calcified tissue residuals.Furthermore severe extraction damages were noted such as a deformed proximal shock coil and a damaged lead tip with missing fixation tines.In the medial lead fragment no conductor fragments were found.During the electrical analysis, the dc resistances of the received conductor fragments of the distal lead fragment were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.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.
Event or Problem Description
It was reported that this lead was fractured with rising impedances since (b)(6) 2020.Lead was explanted and replaced.No adverse patient events were reported.Should additional information become available, this file will be updated.Lead was returned (b)(6) 2020.

• Brand Name: LINOX SMART TD 65/18
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10439539
• Report Number: 1028232-2020-03543
• Device Sequence Number: 16881273
• Product Code: NVY
• UDI-Device Identifier: 04035479100476
• UDI-Public: 04035479100476
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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: 01/31/2012
• Device Model Number: 359074
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 04/12/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 08/28/2020; 04/14/2021
• 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
• Patient Age: 59 YR