MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEADM MODEL 304

Model Number 304-20

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

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 10/23/2017

Event Type  Injury  

Event Description

It was reported that the patient has decreased appetite and was diagnosed with right vocal cord paralysis due to vns lead revision surgery.The patient's new device was programmed to the lowest settings following the surgery and diagnostics were reported to be within normal limits.Lead was replaced due to low impedance and this event was reported in mfr.Report # 1644487-2017-04807.The neurologist and ent are closely monitoring patient's progress.The neurologist does believe that vocal cord paralysis may have caused lack of appetite.

• Brand Name: LEADM 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: 7280279
• MDR Text Key: 100397119
• Report Number: 1644487-2018-00236
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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
• Report Date: 02/19/2018

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: Lay User/Patient
• Device Expiration Date: 09/19/2020
• Device Model Number: 304-20
• Device Lot Number: 203924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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: 14 YR