MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Human-Device Interface Problem (2949)

Patient Problem Dyspnea (1816)

Event Date 11/12/2015

Event Type  Injury  

Event Description

It was initially noted that the patient was referred for prophylactic generator replacement and that nothing was wrong with the leads or generator, the generator has 25% battery left, but he has a dual pin.The physician wants patient to have a new device.Clinic notes dated (b)(4) 2015 were received on (b)(4) 2015 however which indicate that the physician changed the patient's settings from 25hz to 30hz which caused the patient to have a significant coughing episode.The physician indicates that perhaps the device was never active as the change was too minor to cause so much coughing and referred the patient for revision surgery.

Event Description

It was reported that the patient was referred for generator replacement for prophylactic reasons.Although surgery is likely, it has not occurred to date.Diagnostics were performed and were within normal limits.

Event Description

On (b)(6) 2016, the patient underwent prophylactic generator replacement.

• Brand Name: PULSE GEN MODEL 104
• 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: 5304792
• MDR Text Key: 33717731
• Report Number: 1644487-2015-06782
• 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,Followup
• Report Date: 12/01/2015

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: 02/01/2014
• Device Model Number: 104
• Device Lot Number: 202049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2016; 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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): Required Intervention
• Patient Age: 44 YR