MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Loss of Power (1475); Failure to Power Up (1476)

Patient Problem Seizures (2063)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Review of vns device programming history by the manufacturer showed that generator disablement on (b)(6) 2016.Information was received from nurse that the device remains off.Patient parents wanted the device switched off as they felt it made seizures worse and so far haven't allowed turning it back on.Attempts for additional relevant information have been unsuccessful to date.The nurse reported that the situation is complicated by family dynamics which is probably all she can say on the matter.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5821828
• MDR Text Key: 50405082
• Report Number: 1644487-2016-01688
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2016

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: 03/23/2017
• Device Model Number: 106
• Device Lot Number: 4309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• 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