MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

Model Number 300-20

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

Patient Problems Dysphagia/ Odynophagia (1815); Edema (1820); Paralysis (1997); Tissue Damage (2104)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

Event Description

A patient underwent replacement surgery to resolve high impedance present on her vns device, as reported in mfr.Report # 1644487-2016-01548.The surgery was aborted because the explanting physician accidentally punctured the patient's jugular vein, requiring another physician to repair the patient's vein.Per a company representative, the patient stayed in the icu overnight to recover.No additional relevant information has been received to date.

Event Description

The patient's mother reported to a company representative that the patient experienced voice issues, swallowing, coughing, and hoarseness as a result of the injuries sustained during surgery.The patient's family was concerned with the potential for choking while drinking and vocal cord paralysis.The surgeon reported that the patient experienced a lot of swelling but expected the patient's voice to heal.An ent referred the patient for a modified barium swallow test to evaluate the patient's condition.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 300
• 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: 7275417
• MDR Text Key: 100232357
• Report Number: 1644487-2018-00226
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: Health Professional
• Device Expiration Date: 08/30/2003
• Device Model Number: 300-20
• Device Lot Number: 4105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2001
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR