MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S DX 65/17; ICD LEAD

Model Number 365501

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

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

Starting in dec 2023 pacing impedance started trending up to >3000 ohms.Recommended further postural testing and discussed risks with out of range pacing impedance.It was reported that rv pacing capture was lost as well.Lead was explanted and replaced on (b)(6) 2024 a fracture was noted with noise.No adverse patient events were reported.

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.

• Brand Name: LINOX SMART S DX 65/17
• 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: 19188130
• MDR Text Key: 341184127
• Report Number: 1028232-2024-02289
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 04035479110024
• UDI-Public: (01)04035479110024(17)160131
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 365501
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female