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 10/05/2018

Event Type  malfunction  

Event Description

It was reported by the physician that the patient had an increase in seizures, increased notably in frequency and duration compared to the 4 months prior, starting the day after surgery.Prior to implant, seizure rate was 2-4 per month and after implant, it was 1 per day.The believed cause of the increased seizure frequency and intensity was device implantation and not device stimulation as it occurred the date after surgery.There was no believed external contributing factors.The device was off at the time of onset of seizures.Diagnostics were ok at the first visit after implantation.There was no medication change as a result of this event.No further relevant information has been received to date.

Event Description

It was reported that the increased seizure resolution date was 2 months post start date.No further relevant information has been received to date.

Event Description

It was reported that this event of the patient's increased seizure frequency had resolved.No further relevant information has been received to date.

Event Description

It was reported that the type of seizures that the patient was experiencing were noted to be 'psychogenic non-epileptic seizures (pnes)'.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 8123431
• MDR Text Key: 129028703
• Report Number: 1644487-2018-02189
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2020
• Device Model Number: 106
• Device Lot Number: 204520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 03/13/2019; 04/10/2019; 03/15/2023
• Supplement Dates FDA Received: 04/04/2019; 04/16/2019; 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: 21 YR
• Patient Sex: Female