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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Pain (1994); Respiratory Failure (2484)

Event Date 07/02/2012

Event Type  Injury  

Event Description

Clinic notes indicated that a patient went into cardiac arrest with associated respiratory arrest when he was given opioid pain medication shortly after his initial vns implant surgery.The medical team was administering the medication every 6 hours after surgery had occurred.Around midnight on the date of surgery, the staff noticed that the patient's breathing pattern had changed, leading to the cardiac arrest.An ambulance was called, and the patient was defibrillated.The physician concluded that the cardiorespiratory arrest was an adverse reaction to the pain medication and not caused by the placement of the vns.Clinic notes from later clinic visits indicated that the device was functioning properly.No additional relevant information has been received to date.

Event Description

The physician reported that the opioid painkillers were administered to the patient prophylactically.The physician also noted that the patient was non-verbal, so it could not be determined if or where the patient was experiencing post-surgical pain.No additional relevant information has been received to date.

• 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: 6820596
• MDR Text Key: 83648346
• Report Number: 1644487-2017-04363
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 103
• Device Lot Number: 202105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2012
• 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): Life Threatening; Required Intervention
• Patient Age: 31 YR