MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Pain (1994); Seizures (2063); Cognitive Changes (2551)

Event Date 12/02/2019

Event Type  Injury  

Event Description

The patient was referred for a generator replacement due to having a battery status of ifi (intensified follow-up indicator)=yes.The patient then reported experiencing breakthrough seizures which have caused confusion and headaches causing the patient to call off from work.The patient also reported a history of seizures since vns implant, some of which have included er/hospitalization afterwards.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.Per the physician the reported increase in seizures was due to low battery and was below pre-vns baseline levels.The physician also assessed the headaches and confusion to not be related to vns but to an external factor.The intervention taken for the patient's headaches and confusion was for patient comfort and the adverse events resolved with the change in medication.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 9497472
• MDR Text Key: 173285023
• Report Number: 1644487-2019-02476
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2014
• Device Model Number: 103
• Device Lot Number: 202073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• 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: 42 YR