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

Model Number 106

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

It was reported that, after a hysterectomy procedure on (b)(6) 2018, the patient suspected her vns device was not working.The patient's neurologist reported that the patient visited two days later ((b)(6) 2018) to check her vns device.The neurologist stated that upon interrogation it was found that the device's output current were had been set to 0ma due to an unknown reason.The exported programming data from the neurologist's programming tablet was received and reviewed.The data showed no indication that the device's output currents were disabled.There was no indication of a malfunction from the available data.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7631551
• MDR Text Key: 112170129
• Report Number: 1644487-2018-01069
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2018
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• 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: 37 YR