MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Seizures (2063); Cognitive Changes (2551)

Event Date 01/07/2019

Event Type  Injury  

Event Description

It was reported via clinic notes received by the manufacturer that the patient was experiencing seizures about every other day, which was an increase.The patient felt that her memory had gotten worse with the increase in seizures.It was noted that the vns was still functioning but the battery life was beginning to wane.The patient was referred for vns replacement surgery.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

Follow up with the physician's office revealed that the patient has had uncontrolled seizures since childhood and was first seen by the physician's office this year.The increase in seizures were attributed to the low battery, but the physician was unable to provide an assessment on how this compared to the pre-vns baseline.The physician stated he would have a better assessment on the worsening memory and its relation to vns after the generator replacement, which has not been provided to date.

Event Description

The patient underwent vns generator replacement surgery due to battery depletion.During attempts at product return, it was revealed that the explanted product was likely discarded as the facility no longer had the product.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8303438
• MDR Text Key: 134964793
• Report Number: 1644487-2019-00228
• 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,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2014
• Device Model Number: 103
• Device Lot Number: 202298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• 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: 54 YR