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

Model Number	369819
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was explanted due to high thresholds.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut approx.11 cm distal to the is-1 pin.A proximal, a 59 cm long medial as well as a 7 cm long distal fragment were received for analysis.The medial and distal fragment are still interconnected through the conductors, the medial fragment was retracted 13 cm from the distal fragment.An explantation aid was still inserted in the medial lead fragment.It is reasonable to assume that the lead was cut during the explantation procedure.The returned lead fragment was visually analyzed.The visual inspection revealed that the insulation was, apart from the present fragmentation, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.Damages like the cuts into the insulation, deformations of the conductor coil and the fracture of the conductor cable leading to the rv shock coil and ring electrode most likely occurred during the extraction procedure.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.

• Brand Name: LINOX SMART S 75
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10094192
• Report Number: 1028232-2020-02176
• Device Sequence Number: 3881960
• 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: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 08/31/2013
• Device Model Number: 369819
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: 61 YR