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 Pain (1994); No Code Available (3191)

Event Date 03/06/2006

Event Type  Injury  

Event Description

A patient reported through social media that vns did not work for her and that she also did not like that it made her voice hoarse.It was stated that the generator was disabled.Per the physician's assessment, the patient became seizure free after her second surgery for her brain recurrent brain tumor.It was noted that vns was placed after the patient's first surgery for the brain tumor.The device was disabled for lack of efficacy and because the patient was seizure free after removing her brain tumor.It was also reported that there was pain at the "nonfunctioning vns site".No diagnostics were provided.No additional relevant information was received to date.

• 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: 8083811
• MDR Text Key: 127536096
• Report Number: 1644487-2018-02086
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2007
• Device Model Number: 102
• Device Lot Number: 014188
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2005
• 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: 17 YR