MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 302; LEAD

Model Number 302

Device Problem High impedance (1291)

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

Event Date 07/02/2015

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2015.It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading.Further follow-up found that the patient had been referred for generator replacement surgery.At the time, the surgeon did not want to replace the lead because he was concerned that there may not be enough room on the nerve for a new lead.However it is unclear how the surgeon made this assessment.The generator was replaced on (b)(6) 2015 and the existing lead was connected to the new generator.Following generator replacement a system diagnostic test observed high lead impedance with the newly implanted generator.Programming history indicated that as of (b)(6) 2016 the high impedance had not resolved.The physician was notified of the high lead impedance and the manufacturer's recommendations for addressing high lead impedance events.It was then reported that since the high impedance was observed the non-verbal patient has been agitated and experiencing dysphagia, loss of appetite and trouble sleeping.The device was programmed off on (b)(6) 2016.Following device disablement the patient's behavior and symptoms improved however the patient was still not eating well and appeared to be fearful of food.Attempts to obtain additional information have been unsuccessful to date.It is not known if the lead has been replaced to date.

Event Description

The patient's mother provided an update on her daughter's condition since the device was disabled.She reported that prior to the device being disabled she had taped the magnet over the generator and the patient's behavioral issues improved.However when the mother went to place the magnet she accidentally swiped the magnet and activated a magnet stimulation.The patient reacted to "defend herself" and appeared to be in pain from the magnet swipe.She also reported that the patient had undergone a barium swallow test in (b)(6) 2016 which showed that the patient was suffering from muscle spasms.She was placed on prevacid in response to the muscle spasms.However since the vns device has been disabled the patient is no longer suffering from issues with swallowing.The patient is still exhibiting an aversion for eating however the mother believes this may be a defensive response from the previous issues that were caused with the high impedance.The patient had been previously placed on 4 different sleep medications however none of them improved her sleeping difficulties.The patient is still suffering from issues sleeping since the device has been disabled.

• Brand Name: PULSE GEN MODEL 302
• 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: 5972991
• MDR Text Key: 55873957
• Report Number: 1644487-2016-02173
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: 302
• Device Lot Number: 201284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2009
• 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 Outcome(s): Other
• Patient Age: 16 YR