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); Depression (2361); Neck Pain (2433); No Code Available (3191)

Event Date 10/01/2016

Event Type  Injury  

Event Description

It was reported that the patient was experiencing painful stimulation at her jaw.The patient also had pain in her neck and jaw which made it difficult to move.Therefore the patient was being referred for a possible lead revision due to the pain.Because of these symptoms the patient was experiencing issues with depression.No additional relevant information has been received.No surgical interventions are known to have occurred to date.

Event Description

Further information was received that the surgeon intended to perform surgical intervention for the lead when the generator needed to be replaced since at this time, the generator was still functional.No further relevant information has been received to date.

Event Description

Incoming information was received indicating the patient's device was to be upgraded and the patient was referred for surgery.Follow up with the patient stated that generator replacement was needed due to low battery.It was stated that the surgeon would also take a look at her lead as she reported that the lead was "all clumped up under her neck" and that when she turns her head to the right, she can see the wiring under the skin.She stated she could see the "clump" without turning her head.The patient also reported that her generator had migrated and the surgeon stated that when the generator was replaced, he would ensure the device was better secured in the pocket.It was further stated that the patient has near constant ear and toothache believed to be with stimulation and attributed to vns as she had seen both a dentist and ent.She reported a scratchy voice that worsens with stimulation and makes her feel like she has to gasp for air to continue conversations.It was noted that the patient otherwise has been doing well with vns and sees decrease in seizures with the device.The replacement surgery occurred.It was stated that the leads were not revised as they tested to be functioning within normal limits.Post-operation diagnostics showed the devices were functioning as intended.No device was expected for return per the hospital policies.No additional 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6914216
• MDR Text Key: 88164770
• Report Number: 1644487-2017-04543
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 3832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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: 56 YR