MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Discomfort (2330); Hypoesthesia (2352); Implant Pain (4561)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

Event Description

The patient complained of pain and tingling at the generator site and down the left arm to the elbow.Ct scan was performed.The physician noted that this is occurring 1-2 times a day, and it is unclear if it is positional.Settings were not adjusted.It was noted that the patient had two episodes where her left arm shot up and she thinks the device may have fired.It was observed that 32 autostimulations were provided that day.The medical professional noted she spoke to the patient about the ongoing pain at the generator and lead site and shocks.It was noted the patient came to the er in december for swelling and ct did not show any lead break at that time, but due to the new shocking sensations she ordered another chest and neck x-ray to evaluate the placement of the leads.The patient's mom noted that someone who checked the device noted they would still feel some swelling around the generator, noting it is still 30% swollen.Information was received from the physician.Regarding the cause of the events, he notes there are no sensory or strength abnormalities noted on his exams.He notes that it seems possible that the spasm could have been related to stimulation however cannot guarantee that it correlated at the same time that the device fired.He notes the cause of the swelling is unclear and he is not aware of any trauma or manipulation to the device site.They plan to potentially turn the device off temporarily to confirm if the events are related to stimulation.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Information was received that patient was disabled a week after pain was experienced.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 13737194
• MDR Text Key: 287135495
• Report Number: 1644487-2022-00254
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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: 07/15/2023
• Device Model Number: 1000
• Device Lot Number: 205744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 18 YR
• Patient Sex: Female