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

Model Number 102R

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

Patient Problem Seizures (2063)

Event Date 08/25/2017

Event Type  Injury  

Event Description

It was reported that the patient is starting to have an abundance of seizures recently.It was stated that system diagnostics were performed and were normal but no value was provided and battery was not near end of service.Her father stated that since the last vns check she is having seizures every 3 days.The patient is recommended to have battery replacement despite the battery not being low.It was noted that it has been 10 years since the last device was implanted and even though the settings have not changed since the last clinic visit she continues to have increased seizure frequency which may be due to weakened battery.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

Additional information was received indicating that this was a very difficult patient.The last time she was seen they tried to increase her settings for efficacy and the patient was very dramatic and coughed with the increase although the nurse thinks that it was not actually brought on by the stim but more for show from the patient who has always been dramatic when changing settings.She said that the mom wanted to see a different provider because they thought that this nurse was causing harm (by increasing settings) so she saw a different nurse in the same facility who turned the vns back down to 0.25 ma.The device was confirmed to be functioning normally and system diagnostics were normal.It is not known if the increase in the seizures was above, below or back to pre-vns baseline levels.As mentioned the nurse has tried to increase settings but patient won't tolerate, but she thinks the low settings is low efficacy.No additional or relevant information has been received to date.

Event Description

The patient underwent prophylactic replacement to replace the 102r generator with a 104 generator.The explanted generator has not been received for analysis.No additional or relevant information has been received to date.

Manufacturer Narrative

Describe event, corrected data, supplemental medwatch #2 inadvertently omitted information already known prior to submission.Device available for evaluation?, corrected data, supplemental medwatch #2 inadvertently omitted product received date.

Event Description

The explanted generator was received for analysis.Product analysis on the generator was completed and approved.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results of the generator being placed in a simulated body temperature environment showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

• Brand Name: PULSE GEN MODEL 102R
• 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: 6959457
• MDR Text Key: 89672389
• Report Number: 1644487-2017-04641
• 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,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2008
• Device Model Number: 102R
• Device Lot Number: 015168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2006
• 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: 25 YR