MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Complaint, Ill-Defined (2331)

Event Date 06/26/2014

Event Type  Injury  

Event Description

Additional information was received stating that the vns patient had complete paresis of the left two vocal cords.

Event Description

It was reported that the patient has severe vocal cord damage and will be seen by a specialist.No additional relevant information has been received to date.The patient is not currently implanted with vns as the patient was explanted due to infection.The infection was reported in mfr.Report # 1644487-2014-01836.

Event Description

Additional information was received that the patient's voice hoarseness has improved and that the patient's voice was good currently with treatment from the ent.Due to increased seizures, patient plans to pursue vns therapy again.

Event Description

It was reported that the recently re-implanted vns patient was suffering from voice hoarseness.The patient was referred to an ent specialist.The neurologist stated that the voice hoarseness was believed to be due to vocal cord paralysis or nerve damage.

Manufacturer Narrative

Event Description

Additional information was received that the patient was re-implanted with a new vns system on (b)(6) 2015.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 4092866
• MDR Text Key: 5010187
• Report Number: 1644487-2014-02354
• 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: Other,Consumer,Health Professional,Company Representative,company represent
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 304-20
• Device Lot Number: 3896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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): Other
• Patient Age: 49 YR