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 Fatigue (1849); Hypoesthesia (2352); Neck Pain (2433)

Event Date 02/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported that the patient had their generator replaced due to prophylactic reasons and the generator showing the "intensified follow up indicator".Further information was received that ever since the patient's seizures have stopped, the generator feels as if it is continuously stimulating (similar to magnet mode stimulation going off constantly).The patient was noted to be experiencing throat tightness, hoarseness, tingling of the head and generalized fatigue.This report is contained in manufacturing report number: 1644487-2021-00007.It was noted a similar issues occurred for the patient's first vns which required replacement (initially reported to be due to prophylactic reason).The patient's explanted device has not been received into analysis to date.No additional relevant information has been received to date.

Event Description

Information was received that per the physician the cause of the current present symptoms of continuous stimulation, painful stimulation (throat tightness), voice alteration, hypoesthesia, and fatigue are related to vns stimulation and "possibly" due to low battery (this report contained in manufacturing report number: 1644487-2021-00007) as the patient reported similar symptoms in 2015 when the generator battery life was at end of service.It was stated that per the physician, the current and previous battery replacements were performed in 2015 and 2020 due to the patient's report that he feels the vns device was/is firing abnormally, as if the magnet is being used constantly.Generators were both replaced for patient comfort and to preclude a serious injury.No additional 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
• MDR Report Key: 11109126
• MDR Text Key: 224803272
• Report Number: 1644487-2021-00006
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: 10/30/2011
• Device Model Number: 103
• Device Lot Number: 2590
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR