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

Model Number	359074
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.85 months, it was reported that the shock impedance was too high.During the icd-system revision it was observed that the lead was fractured proximal to the connector.The lead was capped.
Additional Manufacturer Narrative
A portion of the lead was returned for analysis.The icd was not returned for analysis.Therefore this report only refers to the review of the quality documents associated with the manufacture of the lead and the icd, the analysis of the returned data as well as the analysis of the lead itself.The returned data were thoroughly inspected.The inspection revealed an increasing shock impedance with values of greater than 150 ohm, confirming the clinical observation.The pacing impedance showed a normal behavior.The lead was not completely returned for analysis.Only a 3 cm long fragment with the df-1 connector pin was returned.However the corresponding conductor cable was not available.The performance of the fragment was scrutinized, including a visual inspection.During the visual inspection the conductor cable leading to the rv shock coil was found torn from the df-1 connector pin.Unfortunately an analysis of the missing lead fragment would be necessary to determine the root cause of this damage.Cuts into the insulation were detected 2 cm distal to the df-1 connector pin.This damage most likely occurred during the extraction procedure.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.The manufacturing processes for both the icd and lead were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test of the icd proved the device functions to be as specified.In conclusion, there was no indication 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
• MDR Report Key: 9979520
• Report Number: 1028232-2020-01758
• Device Sequence Number: 14311591
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 02/28/2014
• Device Model Number: 359074
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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