MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Paralysis (1997)

Event Date 09/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a vns patient is having vocal cord paralysis.The paralysis began after the patient underwent a full vns system replacement surgery.Information was received that the patient was implanted on the right vagus nerve.Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Follow up information received that the patient has been implanted on right vagus nerve because it was impossible to find a place to attach the electrode on the left side when the previous lead had been removed.This was due to adherences on the vagus nerve.The generator has been implanted on the right side as well.Both right and left vocal cords are paralyzed and physician believes this is definitely related to vns surgery.The left vocal cord was completely paralyzed, the right vocal cord partially paralyzed.The implanted generator has never been programmed on.No diagnostic test results available.The patient has had tracheostomy and still has his tracheostomy with a tracheal cannula in place.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 6066750
• MDR Text Key: 58743226
• Report Number: 1644487-2016-02520
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2017
• Device Model Number: 106
• Device Lot Number: 4536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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 Age: 56 YR