MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Fatigue (1849); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a nurse that she has a patient, implanted recently with a gvns enerator model 106, who has suffered from vomiting and fatigue.The patient came on 2 visits where they respectively turned on and increased the output.On both visits, the patient suffered from vomiting and fatigue in the next days.After the second visit, the patient even was admitted in hospital.The patient's device was only programmed at 0.5ma output current at that moment, and she was not coughing or anything during stimulation.It was reported that the nurse continued to increase the output and advised the patient to call if she feels the symptoms again and drink a lot.It was reported by the nurse that she was wondering this might be due dropping blood pressure.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.Additional information from the nurse indicated that the patient was implanted on (b)(6) 2016.It was reported that the event started after the device was switched on, on the first visit.It was reported that the patient has no history of those events prior to vns implantation.No recent medication changes that could have contributed to the events.It was reported that the patient did not suffer with low blood pressure prior to implantation.It was reported by the nurse that she saw the patient on (b)(6) 2016 for a follow-up: she has not suffered anything other than fatigue since last visit when the nurse reduced the signal frequency to 20hz.However the patient is unable to tolerate any output higher than 0.75ma.It was reported that any increase of the output current leads to coughing and gagging throughout the whole stimulation.No additional information was provided to date.

Event Description

Additional information was received from the nurse indicating that the patient's device settings were 0.75ma output current - 20hz frequency - 250c pulse width - 7sec on time - 1.8min off time 1.8.It was reported that the device tests were run and system diagnostics returned impedance results within normal limits.It was reported that the patient had not been noted to have low blood pressure (bp) prior to implantation.On admission to the facility with the initial fatigue and vomiting, she was seen to have low bp.The nurse has not checked the patient's bp in clinic and the problem appears to have resolved since the reduction in signal frequency.

• Brand Name: PULSE GEN MODEL 106
• 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: 5969521
• MDR Text Key: 55328679
• Report Number: 1644487-2016-02157
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: 106
• Device Lot Number: 4735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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): Hospitalization
• Patient Age: 38 YR