MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 75/18; ICD LEAD

Model Number	359068
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was explanted due to high impedances.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 subjected to an extensive analysis.The performance of the device was scrutinized, including a visual, electrical and mechanical inspection.The visual inspection showed abrasion marks along the lead body.In particular, approximately between 45cm and 48cm distal to the is-1 connector pin and between 64cm and 66cm distal to the is-1 connector pin the inspection revealed a rubbed through insulation.The conductor cable to the rv shock coil was fractured.This finding can be considered the root cause of the reported high impedances.Based on the characteristics of these damages, it is reasonable to assume that the lead was subject to severe mechanical stress in the implanted state due to constant friction against another implantable device such as a nearby lead.Diagnostic images clarifying this assumption were not available.Furthermore, deformations of the shock coil were found which resulted most likely from the extraction procedure.The manufacturing process for this lead 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 SD 75/18
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8640407
• Report Number: 1028232-2019-02126
• Device Sequence Number: 1941389
• Product Code: NVY
• UDI-Device Identifier: 04035479100414
• UDI-Public: 04035479100414
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 12/31/2016
• Device Model Number: 359068
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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: 64 YR