MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 09/29/2015

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2015 report that the patient had a motor vehicle accident on (b)(6) 2015.Since that time, he was experiencing regular shocking sensations in his left face with timing consistent with the vns cycling.The shocking sensation was stronger with magnet stimulation.The patient went to the hospital where x-rays were taken which reportedly did not show any abnormalities with the vns system.The patient had an appointment scheduled with the surgeon on (b)(6) 2015.The neurologist performed diagnostics and all diagnostic testing was normal with normal lead impedance.He assessed that there were no apparent problems on electrical testing.The device was turned off, and the patient had no further shocking sensations.So at that time, the device was left programmed off.The plan was to turn it back on to tolerated settings if the surgeon found no problems with no plans for a procedure.Upon follow-up, the surgeon's office upon follow-up that the patient went to the er for the shocking sensation from the motor vehicle accident and then had surgery on (b)(6) 2015 due to the shocking sensation.No additional relevant information has been received to date.

Event Description

Operative notes from (b)(6) 2015 were received and reported that the patient had felt random shocks from vns since the motor vehicle accident at the end of (b)(6) 2015.Even when taping the magnet over the generator, the shocking feeling persisted.The neurologist therefore programmed the device off and was referred the patient for explant.The generator was explanted on (b)(6) 2015.The surgeon noted that no abnormalities were noted.The operative notes indicated the device was sent back for analysis, but it was not received.The company representative checked with the hospital, and it was reported the device was discarded.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 5331293
• MDR Text Key: 34525854
• Report Number: 1644487-2015-06679
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 105
• Device Lot Number: 3817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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): Required Intervention
• Patient Age: 34 YR