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

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Cardiac Arrest (1762); Dyspnea (1816); Unspecified Infection (1930); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/02/2017

Event Type  Injury  

Event Description

An article was received that reported multiple adverse events and a malfunction.The current report captures the adverse events associated with the generator.Mfr.Report # 1644487-2017-04155 captures the malfunctions reported by the article.Mfr.Report # 1644487-2017-04154 captures adverse events associated with the lead.There was one intraoperative adverse event associated with the generator.This patient experienced transient asystole intraoperatively.This event resolved without treatment and did not require cardiopulmonary resuscitation.There were three reported post-surgical complications related to the generator.There was one patient that presented with wound dehiscence one week post-surgery that was managed surgically.Another patient presented with an infection at both generator and neck sites; this patient had full recovery after being treated aggressively, first with iv antibiotics for one week and second with oral antibiotics for another week.The last patient experienced post-operative status epilepticus that required 3 days intubation and icu admission; this was most probably related to general anesthesia used during surgery.The article reported that 10 patients experienced laryngeal side effects associated with stimulation (coughing, hoarseness and shortness of breath) that were proportional to amplitude, frequency and duration of stimulation.These patients all presented with a significant increase in vocal handicap index.These patients were found to have decreased left cord mobility that was more significant with vocal cord abduction.The left cord in the resting position was shorter and more medially-positioned than the right vocal cord.None had complete vocal cord paralysis and their voice changes did not affect their ability to communicate and shortness of breath was mild.None needed medical or surgical treatment.Vocal hoarseness resolved in patient's no longer receiving therapy.One patient experienced an increase in seizures with vns therapy.The patient' caregivers requested vns removal.No further relevant information has been received to date.

Event Description

The surgeon indicated that in the study there was never a problem in the generators or their ability to deliver therapy.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNK
• 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: 6723189
• MDR Text Key: 80381286
• Report Number: 1644487-2017-04153
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention