MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 60; ICD LEAD

Model Number	375012
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Lead explanted in 2017 due to noise causing inappropriate shocks.Lead was returned to biotronik for analysis on 16-aug-2021.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 11cm distal to the is1 connector pin.The proximal fragment was received for analysis.The distal fragment including the rv shock coil and lead tip was not returned.The returned lead fragment was visually analyzed.The visual inspection revealed that the insulation was, apart from the present cut, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observations.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 60
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12454518
• Report Number: 1028232-2021-05044
• Device Sequence Number: 14786670
• Product Code: NVY
• UDI-Device Identifier: 04035479116194
• UDI-Public: 04035479116194
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 375012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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: 45 YR