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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures, Grand-Mal (2168)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was reported that the patient was experiencing an increase in seizures characterized by myoclonic jerking.These started approximately one year prior to the beginning of their mention in the clinic notes (date of notes was (b)(6) of 2016).The physician attributed the increase in seizures to battery depletion.The physician expressed he would seek generator replacement for the patient.Surgical intervention has not occurred to date.Follow up with the office of the treating physician¿s office showed that they suspected the battery to be low, but could not identify if the generator registered a low battery indicator at that time.Device diagnostics from that time could not be indicated.The patient was reportedly not taking any antiepileptic drugs, but this was not a recent change and could not be linked to the increase in seizures.No other relevant information could be provided at that time.

Event Description

The patient's generator replacement surgery occurred on (b)(6) 2016.Prior to explant, the patient's battery was reported to not be at end of service, and the device diagnostics were within normal limits.The explanting facility does not return explanted devices; therefore, product return attempts could not be completed.No additional pertinent information has been received to date.

• 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: 5947422
• MDR Text Key: 54625805
• Report Number: 1644487-2016-02068
• 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: 08/19/2016

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: 12/31/2007
• Device Model Number: 102
• Device Lot Number: 014911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2006
• 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: 24 YR