MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

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

Patient Problem Paralysis (1997)

Event Date 12/30/2005

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the event has been attributed to the placement/surgery for the vns and is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had complained of hoarseness uncorrelated with generator ¿on¿.The patient said that it had been worse the ¿last several years¿.This hoarseness had been present since the patient was first implanted.The surgeon believed it was likely due to the low placement of the first lead implanted because it was close to the vocal cords.The surgeon thought that the patient may have vocal cord paralysis.It was also possible that the patient was just old.No known surgical interventions have occurred to date.No further relevant information has been received to date.

Event Description

It was reported by the surgeon's office that vocal cord paralysis was not verified.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 7376026
• MDR Text Key: 103645728
• Report Number: 1644487-2018-00471
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1102
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2005
• 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: 46 YR