MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 75; ICD LEAD

Model Number	369819
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
This lead was explanted and replaced due to vascular occlusion.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 10.5 cm distal to the is-1 connector pin.The proximal and distal fragments were received for analysis.The medial fragment (approximately 26 cm length) was not returned.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the surgery.The returned lead fragments were analyzed.The inspection revealed that the insulation was, apart from the present cut, free of breaches.Further analysis of the returned lead fragments did not reveal any irregularity that might have contributed to the reported clinical observation.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: LINOX SMART S 75
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 10393719
• Report Number: 1028232-2020-03327
• Device Sequence Number: 1896497
• Product Code: NVY
• UDI-Device Identifier: 04035479112981
• UDI-Public: 04035479112981
• 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: 2013
• 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): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 369819
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 01/18/2022
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/13/2020; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male