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

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes were received for the surgery referral of a patient desiring to have the vns system explanted.The clinic notes were reviewed and state that the patient was initially referred due to discomfort at the vns generator location.The neurologist had recommend neurosurgery to evaluate the location of the vns generator to see if it can be moved more medially to relieve patient's pain.During the consultation appointment, the surgeon noted that the patient has tenderness where the generator is located and the generator is slightly protruding from their left armpit.During consult, the patient went on to report that the vns device has not helped their seizures and has actually made them worse, stating that the seizures occur more frequently than prior to the device being implanted.The patient also reports having new ¿double¿ seizures that occur in clusters.The patient also noted that their memory has been worse than before vns.The patient wants to the vns device removed as it has not provided any benefit and noted that the magnet does not help with her seizures either.It was also mentioned that the neurologists notes have not reported the vns worsening the patients seizures, but the patient stated otherwise.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient's entire vns system was explanted.The patient's explant surgery facility is a no return site therefore product has not been received into analysis to date.No additional relevant information has been 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: 8888575
• MDR Text Key: 154147035
• Report Number: 1644487-2019-01565
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575006
• UDI-Public: 010542502575006
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2019
• Device Model Number: 106
• Device Lot Number: 204057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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): Required Intervention
• Patient Age: 40 YR