MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had called into the physician's office stating the vns generator is no longer lying flat and is now standing up sideways, causing her pain.The patient was referred to a surgeon; however, that surgeon was no longer taking her insurance.The surgeon's office stated they had called the patient back and the patient had stated her chest still hurts a little, but not at bad.She noted she still wanted to see somebody to have the issue taken care of.The patient explained to the surgeon's office there was no trauma or injury that caused the issue.Attempts for additional information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

Additional information from the patient was received.She stated she recently saw the physician and it was noted the vns was working fine.It was also noted the vns was in the correct spot and not moving around.The patient was no longer in pain, so the physician has decided to wait and not do anything since everything appears to be fine.

• Brand Name: PULSE GEN MODEL 105
• 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: 6019430
• MDR Text Key: 57053205
• Report Number: 1644487-2016-02333
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: 11/04/2016
• Device Model Number: 105
• Device Lot Number: 203185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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: 45 YR