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

Model Number	369820
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.84 months, it was reported that there was a low impedance on the ventricular lead.
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 available fragment showed abrasion marks.At 3.5cm distal to the connector pin the insulation was broken on the df-1 connector.Based on the characteristics of the damage, it is reasonable to assume that the connector was subject to severe mechanical stress in the implanted state, most likely due to interaction with the generator housing.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 T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9188734
• Report Number: 1028232-2019-04463
• Device Sequence Number: 16725237
• Product Code: NVY
• UDI-Device Identifier: 04035479112998
• UDI-Public: 04035479112998
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 10/31/2013
• Device Model Number: 369820
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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