MAUDE Adverse Event Report: LIVANOVA USA, INC. 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 06/11/2018

Event Type  Injury  

Event Description

It was reported that when the patient's device was interrogated, frequency was found to be set at 1hz.The most recent charting indicated that when the device was last checked on (b)(6) 2018, the frequency was set at 30hz.It was reported by the mother that the patient had been experiencing an increase in seizures over the last 2-3 months.Upon performing diagnostics, the patient experienced violent vomiting, coughing, and gagging.Settings were adjusted several times until the patient no longer experienced further side effects.Further titration was planned.The programming data was reviewed and it appeared that the device was intentionally disabled and programmed to the 1hz settings.At the same office visit, the output current was reprogrammed back on, but frequency was not adjusted and remained at 1hz.No apparent spontaneous change in settings occurred.No additional relevant information was received to date.

Event Description

It was stated that the patient's pre-vns seizure frequency was unknown, however it was noted that the seizures had drastically increased with the signal frequency set at 1hz.The patient's vomiting and gagging was due to the multiple titrations the patient had in one day, including the frequency jump from 1hz back to 30hz without incremental steps.It was stated that the patient is now doing well with better seizures control and has almost been titrated back to original settings.No additional relevant information was received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8190809
• MDR Text Key: 131198787
• Report Number: 1644487-2018-02385
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/03/2019
• Device Model Number: 106
• Device Lot Number: 204219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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: 17 YR