MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Neck Pain (2433)

Event Date 02/05/2019

Event Type  Injury  

Event Description

It was reported that a patient was experiencing pain in the neck.Follow up was received indicating that the pain was extreme and was not associated with any injuries or seizure, although the patient's last seizure was in (b)(6) 2018 and the patient noted that she may have hit her face during the seizure.It was noted that the patient had not had any recent changes in medication.Per the physician, the patient's device had been programmed off.The pain had become mild and her neck was sore at the lead location.Diagnostics were within normal limits.Settings were adjusted to mitigate the painful stimulation.It was stated that the patient felt as if the nerve was irritated or sore likely due to the painful stimulation.The patient's device was then programmed on, initially to 0.75 ma.However, the patient could not tolerate the stimulation at this current.The settings were then reduced further and the patient was left at reduced settings and no other medical intervention was reported.An implant card was received indicating that the patient underwent a replacement surgery due to "unexplained neck pain".No additional, relevant information was received to date.No device was received for analysis.

Event Description

The device was returned for analysis.Analysis was completed for the returned device.Visual evaluation of the device found markings typical of surgical procedure.The septum appeared cored with no evidence of dried body fluid or corrosion in the connector blocks.Burn marks were also noted on the generator, and were most likely associated with electrocautery procedures.The set screw was not returned.There is damage to the underside of the septum.This is most likely associated with loosening of the set screw process during the explant procedure.The device output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the output signal.The device performed according to functional specifications.Analysis in the product analysis lab concluded proper functionality of the generator with no abnormal performance or any other type of adverse condition.No additional, relevant information was received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8413663
• MDR Text Key: 138570710
• Report Number: 1644487-2019-00477
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2016
• Device Model Number: 102
• Device Lot Number: 3996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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: 24 YR