MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Emotional Changes (1831); Seizures (2063)

Event Date 11/07/2019

Event Type  Injury  

Event Description

Patient presented for generator replacement surgery.Prior to the surgery, the patient noted that their seizures had gotten more aggressive and mood had worsened.The patient had some medication changes.The patient and surgeon were unsure if the increased seizure activity was due to the changes in medication or due to possible generator issue.The patients generator was prophylactically replaced.No other relevant information has been received to date.

Event Description

Information was received noting that the surgeon does not know if the increased seizures and mood changes are related to the vns device or medication changes.The surgery was noted to have been for patient comfort only and not to preclude a serious injury.The patients mother indicated that the vns has worked for the patient and noted that if patient does not have vns, their seizures will increase.No other relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial report: not returned to manufacturer inadvertently not selected.

• Brand Name: PULSE GEN MODEL 104
• 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: 9501044
• MDR Text Key: 174361943
• Report Number: 1644487-2019-02497
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

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: 02/20/2015
• Device Model Number: 104
• Device Lot Number: 202460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/17/2020; 01/27/2020
• Supplement Dates FDA Received: 01/17/2020; 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2013
• 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: 28 YR