MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Dysphagia/ Odynophagia (1815); Ambulation Difficulties (2544); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was admitted to the hospital due to issues including dysphagia, ataxia, weight loss of 10 pounds since (b)(6) 2018 (implant month of current vns generator), an increase in general tonic-clonic seizures and changes in neurological status: lethargy and muscle weakness.The patient's device was turned off to see if symptoms improved.The doctor believed that the patient may have an allergy to titanium.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported by the doctor that when the vns was turned off, the patient's drooling, falling, ataxia and lethargy resolved.The doctor indicated that the cause of the dysphagia and ataxia was unknown but likely vns.The patient's lethargy was thought to be caused by the vns.The patient's weight loss was related to dysphagia.The doctor did not know the cause of the muscle weakness or the changes in neurological status.The doctor indicated that the increase in gtc seizures might have been due to disease progression.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 7939263
• MDR Text Key: 122858247
• Report Number: 1644487-2018-01781
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 1000
• Device Lot Number: 204228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 8 YR