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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 08/28/2013

Event Type  Injury  

Event Description

It was reported through clinic notes the patient felt that vns was not helpful for her.The patient later reported that she had her vns programmed off on (b)(6) 2015, no reason was given, and that using the magnet made her seizures worse.The patient stated her seizures increased during the time she was receiving vns therapy.Additionally, she stated she was willing to give vns another try.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported the patient had a generator replacement on (b)(6) 2016.The replacement was noted to be prophylactic.Attempts for additional information have been unsuccessful to date.

Event Description

The explanted generator was received by the manufacturer for analysis.Product analysis is expected but has not been completed to date.

Event Description

Product analysis for the explanted generator was completed.The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment.The results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.An end of service warning message was verified and found to be associated with the output being disabled by the generator.Burn marks were observed on the generator case, which indicated the generator may have been exposed to an electro-cautery tool during device explant.A reset of the device allowed for an output current to once again be provided for subsequent generator testing.The battery voltage was measured and confirmed an ifi = yes (intensified follow-up indicator) condition.Other than the noted pulse disabled event, there were no additional performance or any other type of adverse conditions found with the generator.

• 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: 5636968
• MDR Text Key: 44610062
• Report Number: 1644487-2016-00968
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2013
• Device Model Number: 103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 41 YR