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

Model Number 106

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

Patient Problems Bradycardia (1751); Skin Discoloration (2074); Seizures, Grand-Mal (2168); Low Oxygen Saturation (2477)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient's father that after the patient's office visit in (b)(6), the seizures were noticeably worse.It was noted the patient had some grand mal seizures that hadn't been seen in years from the patient.It was noted the family was also seeing more seizures where the patient's lips start to change color, and the patient's heart rate and oxygen saturation drop.It was noted the heat rate was in the 40's and the oxygen level was in the 70's or lower.It was noted it take a couple of minutes for the patient to get back to normal.The patient's father stated these types of seizures used to be rare but they are now frequent.It was further explained that the patient initially had well controlled seizures after his replacement on (b)(6) 2016.After the first week post-op, his seizures began to increase.At the office visit in (b)(6) 2016, they adjusted his settings, but during the visit on (b)(6) 2016 they changed the settings back to see if they could mimic the results seen during the initial week post-op.All of the diagnostic results showed the device was working as intended.The nurse practitioner is unsure if the increase is above or below pre-vns baseline levels and is unsure of the cause of hypoxia and she is still monitoring these issues.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported that the patient's increase in seizures was still below pre-vns baseline; however, the nurse practitioner was still unsure of what may have caused the increase in seizures.It was also noted that since the office visit on (b)(6) 2016, the patient has been doing much better.

• Brand Name: PULSE GEN MODEL 106
• 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: 5936349
• MDR Text Key: 54707810
• Report Number: 1644487-2016-02021
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2018
• Device Model Number: 106
• Device Lot Number: 203683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 14 YR