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

Model Number 351337

Device Problems Fracture (1260); High impedance (1291); Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.

Event Description

It was reported that this right ventricular (rv) lead exhibited pacing lead impedance measurements that were greater than 3000 ohms, which was out of range.Technical services (ts) analyzed device data and found that this was an abrupt increase along with a drop in r-wave amplitude and non physiological noise.There was no oversensing.Isometric testing, lead evaluation, and x-rays were recommended.Further testing was performed in clinic including isometrics where noise could not be reproduced.The physician suspected a lead fracture.The patient elected to not have further treatment at this time.No adverse patient effects were reported.Currently, the icd system remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).No device details are available.Received voluntary anonymous medwatch report, mw5153239.

• Brand Name: LINOX TD 65/16
• Type of Device: 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: 19151998
• MDR Text Key: 340854475
• Report Number: 1028232-2024-02158
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 351337
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1