MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Human-Device Interface Problem (2949)

Patient Problems Wound Dehiscence (1154); Dysphagia/ Odynophagia (1815); Therapeutic Response, Decreased (2271); Neck Pain (2433); Weight Changes (2607)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out".Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015.Additional information was received that the patient did not believe the surgeon properly closed the incision.Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up.Patient has also reported difficulty eating and chewing and states that she has lost weight since implant.No known surgical interventions have occurred to date.No additional relevant information has been obtained to date.

Event Description

Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays.The device had still not been turned on as of (b)(6) 2015.No additional relevant information has been obtained to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5250260
• MDR Text Key: 32128991
• Report Number: 1644487-2015-06567
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: 102
• Device Lot Number: 4094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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): Other; Required Intervention
• Patient Age: 48 YR