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

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

Patient Problems Arrhythmia (1721); Paralysis (1997)

Event Date 03/01/2017

Event Type  Injury  

Event Description

An article abstract was received, which indicated that a patient experienced permanent hoarseness and coughing due to left vocal cord paralysis during vns implant surgery.The cause of the vocal cord paralysis was most likely due to manipulation of the vagus nerve during implant, and the patient required further surgery due to the vocal cord paralysis.No further relevant information has been received to date.

Event Description

The patient that experienced vocal cord paralysis also experienced dysphagia, which required an otolaryngology consult and lidocaine injection that resulted in some improvement.The patient subsequently had removal of the entire vns system 4 years after placement.The article also mentioned that bradycardia was an adverse event identified in the some of the operative notes of the study patients.No further relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 6695060
• MDR Text Key: 79348628
• Report Number: 1644487-2017-04112
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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