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 Hyperemia (1904); Pain (1994); Scarring (2061)

Event Date 11/25/2017

Event Type  Injury  

Event Description

Report received that a patient presented to the clinic with pain at the generator site.The patient's mother reported that the area appeared "puffy".The pain was reportedly constant and was not occurring with vns stimulation.The patient denied having any trauma to the site.The physician indicated the pocket incision scar did appear raised but was not red or warm to touch.System diagnostics were taken and results were within normal limits.The physician turned off the vns to assess how it helped the patient.The patient returned to the clinic a few days later with the same pain.The pain had reportedly improved with the vns turned off.However, an area of induration was found just to the left of the vns generator.The physician indicated the pain, raised scar, and induration were indicative of an issue.Further information was received that the physician did not know the cause of the adverse events seen.He reportedly suspected they were related, however.X-rays and blood test were performed but no anomalies were seen.The physician was reportedly concerned that there was another issue occurring that could not be detected by the tests run.A review of the device history record indicated the generator had been properly sterilized prior to release for distribution.No surgical intervention has occurred to date.No other relevant information has been obtained.

Event Description

Further information was received that the patient's generator was replaced.The generator was not returned to the manufacturer for analysis.Further information was received from the patient's physician.He indicated that the pain presented "all of a sudden" and did not seem related to stimulation.However, the pain went away after the vns was turned off.He also thought the induration and pain were related since both occurred on top of the generator site.Finally, he noted the physical changes to the generator site were concerning as it was not clear if the changes would lead to tissue damage.He said that the pain was a problem because the patient could no longer tolerate it on implying this was another reason for requesting the replacement.No further relevant information has been received to date.

Event Description

The explanted device was available for return and analysis.The generator was received and product analysis is underway.No additional or relevant information has been received.

Event Description

Product analysis was completed for the generator.Proper device function was successfully verified in the product lab.In addition, the septum was not cored.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery was 2.988 v indicating intensified follow up indicator = no.There were no performance or any other type of adverse conditions found with the pulse generator.No additional or 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: 7154597
• MDR Text Key: 96046071
• Report Number: 1644487-2017-05089
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2014
• Device Model Number: 103
• Device Lot Number: 3540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/29/2017; 02/28/2019; 04/02/2019
• Supplement Dates FDA Received: 01/11/2018; 03/22/2019; 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2013
• 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: 15 YR