MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problems Break (1069); Fracture (1260); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

An implant card was received by the manufacturer reporting a full revision surgery of patient's vns system due to lead fracture and prophylactic replacement for the generator.The lead impedance after surgery was marked as ok.Additional information was received that the impedance was very high recently and surgery planned.During surgery, the surgeon wanted to test the connection between battery and electrode however, before they could do that the isolation of the lead got damaged during dissection so there was no point testing and they decided to immediately remove and replace the entire electrode.The surgeon reported that there was no obvious damage to the electrode, however, most likely it was indeed damaged but they were unable to pinpoint the exact spot of such damage as the electrode was removed in several pieces after opening both incisions.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5928214
• MDR Text Key: 54542054
• Report Number: 1644487-2016-02002
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: 302-20
• Device Lot Number: 201164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2009
• 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 Age: 11 YR