MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Paralysis (1997)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing voice alteration and dyspnea described as "almost asthma-like symptoms." the patient's treating neurologist referred the patient to an ent physician for evaluation.The ent physician showed that the patient had left vocal cord paralysis.Previously, the patient's vns system had been disabled for 2 months for an evaluation period leading up to the ent appointment.The voice alteration and dyspnea continued in this trail period.Furthermore, it was clarified that the voice alteration began soon after surgery.The patient's treating physicians determined that the vocal cord paralysis and associated voice alteration and dyspnea were related to the patient's vns implant surgery.The patient was stated at that time to be planning to undergo speech therapy to mitigate the effects of the vocal cord paralysis.The patient's device was re-enabled.Device diagnostics were reported to be within normal limits from surgery through the date of this report.No additional pertinent information has been received to date.

• 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: 5980975
• MDR Text Key: 55755733
• Report Number: 1644487-2016-02216
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 304-20
• Device Lot Number: 203516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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; Disability
• Patient Age: 61 YR