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

Model Number 102

Device Problem Low Battery (2584)

Patient Problems Undesired Nerve Stimulation (1980); Hypoesthesia (2352)

Event Date 10/06/2017

Event Type  Injury  

Event Description

It was reported that the patient felt the vns stimulating with a buzzing sensation in her ear.An interrogation found that the generator's end of service indicator was triggered.The patient was then referred for a generator replacement.It is known that m102 generators can begin to behave erratically after the voltage is below 2.2v however it is unclear what the generator's exact voltage is at this time.It was noted that system diagnostics was not performed at the most recent appointment.No additional relevant information has been received to date.No surgical interventions are known to have occurred to date.

Event Description

It was reported by the patient's mother that the patient complained of hearing and feeling vns stimulation.The vns magnet was taped over the generator which inhibited normal mode stimulation.The inhibition helped ease these symptoms therefore the patient went back to the physician and had the device programmed off.

• Brand Name: PULSE GEN MODEL 102
• 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: 7008078
• MDR Text Key: 91288628
• Report Number: 1644487-2017-04740
• 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: 02/09/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2010
• Device Model Number: 102
• Device Lot Number: 200989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2008
• 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