MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

Event Type  Injury  

Event Description

It was initially reported by the patient's sister that the patient had a seizure and experienced painful stimulation with magnet activation following the seizure.The patient's sister wondered if this was the result of a low battery.It was stated the patient's physician was on vacation and unable to check the patient's vns.It was later reported that it was thought that the generator battery was dead.The patient was referred for replacement surgery.The patient underwent replacement surgery, which was reported via implant card as for prophylactic reasons.During attempts at product return, it was revealed that the facility, historically, discards explanted products.It was later reported that the reason for the replacement surgery was due to an increase in seizures and low battery.No additional relevant information has been received to date.

Event Description

Follow up with the company representative revealed that the report of an increase in seizures was an error in terminology when reporting that the patient had a seizure.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8048249
• MDR Text Key: 126447742
• Report Number: 1644487-2018-01993
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2008
• Device Model Number: 102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2007
• 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: 60 YR