MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-30

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/16/2016

Event Type  malfunction  

Event Description

During the patient's full vns revision, a new 3mm lead was implanted.After the lead was implanted, high impedance was observed but the surgeon only attempted to reposition the electrodes on the patient nerve and would not test to see about relieving the back-pressure in the vns generator header or to see if the lead pin was fully inserted into the generator header.A new 2mm lead was implanted which also resulted in high impedance.It was noted the company representative again suggested checking the lead pin insertion, but the surgeon initially dismissed the suggestion.Another surgeon then noted that the lead pin didn't appear to be fully inserted.At that time the pin was re-inserted and the diagnostic results were within normal limits.It was reported the surgeon later noted after the case that he may have prematurely replaced that lead and apologized for the haste decision.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5574680
• MDR Text Key: 43168779
• Report Number: 1644487-2016-00792
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2016

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: Lay User/Patient
• Device Expiration Date: 10/31/2016
• Device Model Number: 304-30
• Device Lot Number: 202312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• 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: 22 YR