MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported on (b)(4) 2015 that during an appointment, intermittent pain with device stimulation was reported.At the appointment that the patient was having painful and continuous stimulation that has been keeping him awake for several weeks.The pain was said to have started about 3 months after implant.The patient's pulse with was reduced to 250us, which did not resolve the issue, but instead seemed to make it worse, so the physician decided to temporarily disable the device to see if this was the result of chronic irritation.When turned off the patient immediately started feeling better.No further relevant information has been obtained to date.

Manufacturer Narrative

Describe event or problem, corrected data, initial mdr inadvertently reported that the medical intervention was to preclude a serious injury.

Event Description

The initial mdr should not have been submitted as there was not indication that the medical intervention (device disablement) was to preclude a serious injury.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 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: 5225716
• MDR Text Key: 31313359
• Report Number: 1644487-2015-06413
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 103
• Device Lot Number: 202953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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: 39 YR