MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Seizures (2063)

Event Date 10/04/2018

Event Type  Injury  

Event Description

It was reported that the patient was experiencing a change in seizure patterns.It was unclear what change had occurred at the time of the initial report.The physician was inquiring about vns involvement.Follow up with the physician's office revealed that the change in seizure patterns had begun since the vns was implanted.It was stated that the patient was experiencing longer seizures of 10-15 seconds compared to the pre-vns baseline of 3-5 seconds and that the patient was experiencing more seizures in the morning after waking up and more rescue medication has been given in the mornings.It was stated that the seizure frequency had remained the same as the pre-vns baseline.The physician did not know the relation between the change in seizure patterns and vns.The autostimulation threshold was adjusted and the patient was referred for blood work and an emu stay.No additional relevant information has been received to date.

Event Description

It was reported in that the patient underwent vns lead explantation surgery due to "lead erosion", which was confirmed to be tissue erosion suspected as due to infection.The infection and tissue erosion were reported in mfr.Report #1644487-2019-01872 and reported as unrelated to the reported increase in seizure duration and intensity.

Manufacturer Narrative

Age at time of event, corrected data: follow-up report #1 inadvertently did not update the patient's age.Date of birth, corrected data: follow-up report #1 inadvertently did not update the patient's date of birth.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8350858
• MDR Text Key: 136512298
• Report Number: 1644487-2019-00324
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2020
• Device Model Number: 106
• Device Lot Number: 5710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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): Other
• Patient Age: 19 YR