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 Scar Tissue (2060); Post Operative Wound Infection (2446); Implant Pain (4561)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.(b)(4).

Event Description

It was reported that the patient would like the vns removed as she had no improvement in her condition after implantation and after a local infection the scar does not look well and even disturbs the patient during sleep.She had resection surgery in 2020 and is now seizure free.The generator has been off since then.Information was received from the physician clarifying that the infection was due to manipulations after surgery.She noted that there were incorrect actions from the local surgeon during dressing change.Now there is a large scar with some keloid formation.She said this might cause the patient pain.The patient notes that the vns moves during sleep which causes pain and disturbs her.Because of this she has to avoid wearing bras with straps.She notes the referral for explant is to reduce pain for the patient and since the patient no longer needs the device as she no longer has seizures.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient's generator and lead were explanted.The cause of the generator moving during the patient's sleep is unknown per the physician, but the patient insists that the generator was not secured properly or something happened after implant.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12977275
• MDR Text Key: 282061588
• Report Number: 1644487-2021-01725
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 103
• Device Lot Number: 203481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2015
• 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; Other
• Patient Age: 30 YR
• Patient Sex: Female