MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Improper Device Output (2953)

Patient Problem Paralysis (1997)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing excessive stimulation.The physician planned to decrease the output currents as a result.Additional information was received that the patient was hospitalized and diagnosed with vocal cord paralysis.Per company representative, the excessive stimulation and vocal cord paralysis were first observed on (b)(6) 2016 respectively.Patient's normal mode, magnet mode and autostim output currents were decreased to 0.250, 0.375 and 0.500 ma respectively.Patient does not have prior history or risk factors for vocal cord paralysis.No causal or contributory factors were identified.The physician's believes that the vns stimulation contributed to the vocal cord paralysis.System diagnostics results were within normal limits.Patient's painful stimulation in the throat and excessive stimulation resolved after the adjustment in settings.Additional confirmation was received that he vocal cord paralysis is on the left side and it is believed to be temporary.It is unknown if the vocal cord paralysis also resolved with adjustment to settings.Patient is yet to follow up regarding this.Patient is to follow up with ent physician to look at the nerve.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 6062535
• MDR Text Key: 58600366
• Report Number: 1644487-2016-02493
• 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
• Report Date: 10/11/2016

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: 12/08/2019
• Device Model Number: 304-20
• Device Lot Number: 4655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• 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
• Patient Age: 56 YR