MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/01/2016

Event Type  Injury  

Event Description

Information was received from the patient's mother that his device had flipped in the subcutaneous pocket.The mother noticed the device had flipped from its original orientation based on an x-ray from august.The patient then sought the opinion of two surgeons to remove their vns device.Both surgeons agreed that the device should be removed.However no surgery has occurred to date.No other relevant information has been received to date.

Event Description

Operative notes were received from the patient¿s generator implantation surgery on (b)(6) 2009.The notes indicated that the surgeon used two absorbable sutures to close the subcutaneous and subcuticular layers of tissue.The notes did not indicate whether the generator was anchored to the tissue with a suture.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6119051
• MDR Text Key: 60622523
• Report Number: 1644487-2016-02572
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

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: 10/30/2010
• Device Model Number: 103
• Device Lot Number: 200969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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
• Patient Age: 28 YR