MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271); Lethargy (2560)

Event Date 10/13/2013

Event Type  Injury  

Event Description

Clinic notes dated (b)(4) 2014 noted that the patient has had increasing episodes where she feels like she is going limp, her head goes ack and her eyes roll back.It was noted that the patient is sleepy the remainder of the day and that this has been occurring for approximately 4-5 months.The device was interrogated and ifi was no.The device output current was increased from 1.75ma to 2ma.The patient was referred for surgery.No known surgical interventions have occurred to date.

Event Description

Clinic notes were received for reimbursement purposes on (b)(6) 2015.Notes dated (b)(6) 2015 indicate that the patient's generator is 10 years old and that it is nearing end of life.Patient was also reported to be having seizures and was referred for generator replacement.Notes dated (b)(6) 2015 from the generator replacement surgery indicates that the patient had increased seizures.

Event Description

Patient underwent prophylactic generator replacement on (b)(6) 2015.The explanted generator was reported to be discarded.

• Brand Name: PULSE GEN MODEL 102
• 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: 4329443
• MDR Text Key: 5212542
• Report Number: 1644487-2014-03309
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 102
• Device Lot Number: 015424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2006
• 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: 27 YR