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

Model Number 103

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that a patient experienced neck and jaw painful stimulation that started in (b)(6) 2015.The physician did not believe that the pain in the neck and jaw were consistent with vns stimulation.The patient had an mri, which did not show a lead fracture, according to the physician.However, the patient then started complaining of shooting pain periodically throughout the day.The physician decided that the patient would have revision surgery.Attempts for further information were unsuccessful, and no surgical intervention has occurred to date.

Event Description

Further information was received indicating that the patient felt the shooting pain in his neck, and the surgery was being done for patient comfort only.The patient had generator replacement surgery on (b)(6) 2016.The explanted generator is expected for return, but it has not been received to date.

Event Description

Analysis of the generator was completed on 03/08/2016.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The generator was at an ifi = no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5372764
• MDR Text Key: 36225107
• Report Number: 1644487-2016-00125
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: 103
• Device Lot Number: 202121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2012
• 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: 76 YR