MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Seizures (2063)

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was reported that the patient's seizures had increased since sometime in 2017.It was reported that the patient's medications were changed after seeing another neurologist in 2015 and the patient's current nurse practitioner was unsure if the increased seizures was associated with a medication change or with the depletion of the vns battery.A battery estimation was calculated and did not indicate the device's battery was depleted during the time in increased seizures began.The patient was referred for replacement surgery.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The patient's nurse practitioner unable to assess if the increase in seizure frequency was above pre-vns seizure rate or not.The patient's generator was unable to be interrogated on date of explant due to expected low battery.The patient underwent vns generator replacement surgery due to low battery.The suspect product was reportedly discarded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7900319
• MDR Text Key: 121435240
• Report Number: 1644487-2018-01671
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 102
• Device Lot Number: 2740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2010
• 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: 45 YR