MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 12/02/2016

Event Type  malfunction  

Event Description

It was reported the patient had an office visit with his following neurologist, and when the vns was tested, high impedance was observed.The physician programmed the normal mode and the magnet mode off and the patient was referred for replacement.Clinic notes were received in regards to the patient's replacement referral.The notes stated the patient continues to have frequent seizures and reports his vns does not seem to activate when the magnet is swiped.It was noted within the same visit that high impedance was observed.It was later explained that the patient does not know the date when he first noticed the magnet was not activating the vns stimulation; however, he did state that it was previously working.No known surgical interventions have occurred to date.

Event Description

It was reported that the patient underwent full revision surgery.The devices were reportedly explanted due to high impedance.The patient's explanted devices were discarded after surgery and thus are unavailable for analysis.No additional relevant information has been provided to date.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 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: 6212358
• MDR Text Key: 63497261
• Report Number: 1644487-2016-02958
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

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: 11/30/2000
• Device Model Number: 300-20
• Device Lot Number: 18102C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 18 YR
• Event Location: Other
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/1998
• 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: 53 YR