MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/18; ICD LEAD

Model Number	359074
Medical Device Problem Codes	Impedance Problem (2950); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this lead was explanted due to increasing threshold and impedance after the implantation period of approx.141 months.No adverse patient events were reported.Should additional information be received, this file will be updated.
Event or Problem Description
It was reported that this lead was explanted due to increasing threshold and impedance after the implantation period of approx.141 months.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 27 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment including the yoke and connector pins was not returned.An extraction aid was found on the fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed multiple abrasion marks along the lead fragment.In particular the insulation in the distal end region was found rubbed through.In this region the conductor cable leading to the rv shock coil was found fractured.Based on the characteristics of these damages, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve should be taken into consideration.Further analysis revealed calcified tissue residuals along the lead fragment which had impact on the maneuverability of the lead and led to excessive mechanical stress.Calcification is known to cause high impedances and pacing thresholds and is thus assumed to be the root cause of the clinical observations.Damages such as deformed shock coils, most likely resulted from the extraction procedure.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: LINOX SMART TD 65/18
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13569993
• Report Number: 1028232-2022-00869
• Device Sequence Number: 14457738
• Product Code: NVY
• UDI-Device Identifier: 04035479100476
• UDI-Public: 04035479100476
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 02/29/2012
• Device Model Number: 359074
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown