MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/24/2014

Event Type  malfunction  

Manufacturer Narrative

Event Description

During an internal review of programming and diagnostic data, it was found that the vns patient's device was tested on (b)(6) 2014 and system mode diagnostic results revealed high impedance (dc/dc code 7).The device was then switched off.On (b)(6) 2015, the device was turned on and new tests were run: system diagnostics returned again high impedance with dc/dc code 7.Then the device was again switched off.Further information was received from the physician, indicating that the patient's device was definitely switched off on (b)(6) 2015 because it did not seem to have provided much if any clinical benefit since it was implanted.It was reported that the device was not explanted since, as the patient is not keen to have it explanted.No known surgical interventions have occurred to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 5427040
• MDR Text Key: 38532885
• Report Number: 1644487-2016-00277
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/10/2016
• 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