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); Cognitive Changes (2551)

Event Date 06/28/2017

Event Type  Injury  

Event Description

It was reported that the patient was experiencing an increase in seizures which was causing cognitive changes.The physician believed the cause for the increase in seizures was due to the patient not being able to swipe the vns magnet and the battery being implanted for so many years.However it was noted that the battery indicator was green, indicating it was still functioning.The patient was referred for a generator replacement however no surgical interventions are known to have occurred to date.

Event Description

The patient underwent surgery to have the vns generator replaced prophylactically.The explanted generator was received and is pending product analysis.

Event Description

Analysis was completed on the explanted generator.Upon receipt the generator would interrogate normally and the battery indicator was eri = no, indicating that the device's battery was not low.The reed switch, which activates stimulation when the vns magnet is swiped, was tested and showed to be functioning to specification.The output signal of the generator was monitored for more than 24 hrs, 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 that the device provided the expected level of output current for the entire monitoring period.The device performed to functional specification.

• 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: 6805604
• MDR Text Key: 83092509
• Report Number: 1644487-2017-04330
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2015
• Device Model Number: 102
• Device Lot Number: 202460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/03/2017
• 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: 55 YR