MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature Discharge of Battery (1057)

Patient Problem Seizures (2063)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2015 note that the patient has had many more seizures in the last month than previously.The battery level was noted to be 1/3.Device settings were adjusted and it was recommended for the patient to do prophylactic magnet swipes every four hours since the seizures have become more significant with more pain.It was reported that the increase in seizures was above the patient's pre-vns baseline frequency.The device was rechecked on (b)(6) 2015.It was reported that since the patient is using the magnet prophylactically the battery is being consumed faster.The patient will be referred for generator replacement.No known surgical interventions have been performed to date.

Event Description

The patient underwent generator replacement due to end of service.The explanting facility has policy of not returning explanted devices; therefore, no product analysis can be performed.

• Brand Name: PULSE GEN MODEL 103
• 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: 5011296
• MDR Text Key: 23342126
• Report Number: 1644487-2015-05540
• 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: Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 103
• Device Lot Number: 3065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2011
• 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: 25 YR