MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Cyanosis (1798); Seizures (2063); Numbness (2415)

Event Type  malfunction  

Event Description

It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month.The patient could not talk due to cyanotic lip.The patient has 5 times of seizure where 3 were stopped by magnet.The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline).The patient parameters are currently at: 1.75ma, 30hz, 250usec, 30sec on and 1.8min off.Follow up indicated that the patient¿s parameters were changed to 1.25ma; 250's; 30s on; 5mins off.The patient feels very little numb during stimulation.The patient will come back after 3 months for the next follow up visit.The drugs were not changed.The seizure start area in the brain is still unknown for the physician.It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe).Further follow up indicated that the vns system works fine.Numb feeling disappeared after the parameters decrease.However; the patient has several general seizures after this parameters change.Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns).It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 6016651
• MDR Text Key: 57103619
• Report Number: 1644487-2016-02325
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 102
• Device Lot Number: 203075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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: 20 YR