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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Neck Pain (2433)

Event Date 10/01/2013

Event Type  Injury  

Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014.Additional information was received stating the neck pain was the reason for the replacement surgery.The patient began experiencing the pain around (b)(6) 2013.The pain occurred with stimulation and ceased when the magnet was used to disable the device.Diagnostic results revealed lead impedance to be within normal limits (impedance value ¿ 3114 ohms).Causal or contributory programming or medication changes did not precede the onset of the pain.The epileptologist stated that a thyroid lesion may have contributed to the pain.The pain resolved when the device was programmed off and did not recur when the replacement device was programmed on.Attempts for product return have been unsuccessful.

Manufacturer Narrative

Date received by manufacturer; corrected data: the date received by manufacturer was incorrectly reported on the initial manufacturer report.The date should have been (b)(4) 2014.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3675824
• MDR Text Key: 4236569
• Report Number: 1644487-2014-00673
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: 103
• Device Lot Number: 2530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2009
• 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: 40 YR