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

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Complaint, Ill-Defined (2331); Reaction (2414)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that vns patient was admitted to the hospital due to vomiting, coughing and he has lost his voice since the surgery.Additional information was received that the patient is doing better now.The vns therapy was switched on.The patient was in the consultation for further adjustment of the vns parameters.It was reported that there was still no improvement in the patient's voice according to the father.Further follow up with the physician indicated that the side effect is most likely caused by the manipulation of the vagus nerve during the surgery.The physician reported also that the preimplantation laryngeal emg was not performed routinely, so the quality of the nerve before surgery cannot be estimated.In physician's opinion, there are no therapeutic interventions possible at this time.The evaluation of the vocal cords can be done in the future if the problem persists, but the patient will need general anesthesia for the procedure.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5893134
• MDR Text Key: 52630856
• Report Number: 1644487-2016-01895
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 07/25/2016

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: 01/15/2018
• Device Model Number: 106
• Device Lot Number: 4707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 13 YR