MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

Model Number 300-20

Device Problem Low impedance (2285)

Patient Problem Seizures (2063)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Information was received indicating that a low impedance message had been observed with the patient's generator.The patient who has developmental delays was not able to communicate whether there was an altered perception of stimulation.The physician elected to keep the patient's generator programmed on because the benefit would outweigh the risk.It was reported that the patient was experiencing isolated seizures but better than before.No surgical intervention has occurred to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• 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: 6451422
• MDR Text Key: 71487647
• Report Number: 1644487-2017-03507
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2004
• Device Model Number: 300-20
• Device Lot Number: 5757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2002
• 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: 25 YR