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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes were received for a patient providing that she was experiencing sudden pain with swallowing and with turning of the head.Reducing the output and also lowering the pulse width did not improve the pain.Diagnostics were within normal limits.The patient is in referral for surgery, however no known surgery has occurred to-date.Additional relevant information has not been received to-date.

Event Description

Follow-up to the treating physician provided the pain was located in the patient's neck area around the lead.Diagnostics were reported to be within normal limits.

• 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: 5978720
• MDR Text Key: 55670104
• Report Number: 1644487-2016-02205
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 4295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR