MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/16; ICD LEAD

Model Number	359073
Medical Device Problem Codes	High impedance (1291); Under-Sensing (1661); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was capped and replaced due to high impedances, undersensing and noise.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information 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.15.5cm distal to the is-1 connector pin.Only the proximal fragment was received for analysis.The distal part was missing.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 oversensing.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 TD 65/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9396546
• Report Number: 1028232-2019-05208
• Device Sequence Number: 11251253
• Product Code: NVY
• UDI-Device Identifier: 04035479100469
• UDI-Public: 04035479100469
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

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: 05/31/2013
• Device Model Number: 359073
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 10/18/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/05/2019; 10/21/2020
• 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
• Patient Age: 71 YR