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 Dysphagia/ Odynophagia (1815); Seizures (2063); Vomiting (2144); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 10/08/2015

Event Type  malfunction  

Event Description

It was reported by the patient's partner that the patient had had too many grand mals since implant and that his seizures had steadily gotten worse.He indicated that the patient had had around 20 grand mal seizures since having the vns implanted and had many aura type seizures daily.No further relevant information has been received to date.

Event Description

It was reported by the patient's partner that the patient would be getting their device explanted.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's vns was explanted.Product return is not expected as the hospital historically has discarded explanted products.No further relevant information has been received to date.

Event Description

It was reported through clinic notes that swiping the magnet made the patient retch.In the titration notes, it was noted that the patient had gagging and drooling with stimulation as well.Finally, it was reported that the patient had pain in the left side of the neck and hoarseness with stimulation.It was noted that the patient's generator was programmed off and the patient was referred to surgery as he no longer needed the vns.No further relevant information has been received to date.

Event Description

It was reported via return fax that device disablement and explant was for patient comfort and not to preclude a serious injury.The reason for explant was the patient's adverse events.It was noted that the relationship of the patient's seizures to the vns was unclear.The patient had a change in general tonic clonic seizures in 2017-2018 but the patient improved in (b)(6) 2018 with medication changes.It was also noted that the patients retching, grunting, lots of phlegm, snoring and coughing at night were possibly related to activations but that the relationship was unclear.No further 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: 7883304
• MDR Text Key: 120530216
• Report Number: 1644487-2018-01637
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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,Followup,Followup,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2016
• Device Model Number: 103
• Device Lot Number: 203505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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: 58 YR