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

Model Number 102

Device Problem Battery Problem (2885)

Patient Problems Pain (1994); Seizures (2063)

Event Date 07/01/2013

Event Type  Injury  

Event Description

An implant card was received indicating that the vns patient underwent generator replacement on (b)(6) 2014 due to battery depletion.The explanted generator has not been returned to date.

Event Description

It was reported that the patient complained of pain in her throat that comes and goes.The patient was seen by an ent who found nothing wrong.The patient believes that the pain is from vns therapy.The patient reported that the pain has occurred for approximately 8 months.There was no trauma or any unusual occurrences that may have caused the pain.The physician believes that the device battery may be getting low and recommended generator replacement.Clinic notes dated (b)(6) 2014 note that the recurrence of seizures as well as the sore throat may be an indication of end of battery life, but that vns interrogation showed normal lead impedance and no end of battery life.It was noted that this may be preceded by end of effective stimulation when irregular stimulation may occur leading to more frequent seizures.It was noted that the patient would be referred to neurosurgery for generator replacement.It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency.Attempts to obtain additional relevant information have been unsuccessful to date.No surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3704897
• MDR Text Key: 15996450
• Report Number: 1644487-2014-00790
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2007
• Device Model Number: 102
• Device Lot Number: 012303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2005
• 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: 43 YR