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 Problems Dysphasia (2195); Weight Changes (2607); No Code Available (3191)

Event Date 04/21/2020

Event Type  Injury  

Event Description

It was reported by a physician that a patient would like their vns explanted.Clinic notes were received which stated that the patient's generator was unable to be interrogated to be turned off.It was stated the vns is causing the patient difficulties in talking but vns was unable to be interrogated.It was stated that "since the patient is not happy with the vns and is causing her trouble, the physician recommended removing it and was referred for explant.An internal battery life calculation from programming history data showed that the generator battery is likely depleted and is the cause of the failure to interrogate.Information was received that the believed cause of the patient's difficulties talking was related to stimulation.It was stated that per the physician, the patient's explant is for the difficulties in talking and because they are unable to interrogate the device.Further information was received from the patient the patient's physician cannot interrogate the device, however the device is stimulating and stimulating a lot more often and the patient can barely talk, cannot eat, and cannot breathe.The patient wants the device explanted because the patient's seizures are controlled on medicine.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient's generator was explanted due to battery depletion.The patient's replacement surgery facility is a no return site therefore the explanted product has not been received to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient has lost a lot of weight from the vns choking her and that the patient woke up early in the morning because the device was stimulating and the patient was choking.No surgical intervention has been reported to date.No additional relevant information has been 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
• MDR Report Key: 10057960
• MDR Text Key: 191103112
• Report Number: 1644487-2020-00702
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

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: 09/22/2004
• Device Model Number: 102
• Device Lot Number: 7416
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 06/29/2020; 08/21/2020
• Supplement Dates FDA Received: 07/24/2020; 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR