MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Fatigue (1849); Seizures (2063)

Event Date 01/13/2021

Event Type  Injury  

Event Description

It was initially reported that a patient's battery was low.Further information was received from the physician that the patient has been feeling a lot more drowsy than normal and has had an increase in seizure activity lately and the patient was been referred for generator replacement.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 device has been replaced noted to be due to prophylactic reason.The patient's replacement surgery facility is known to discard products after surgery and is a no return site therefore the explanted generator has not been received into analysis to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11283370
• MDR Text Key: 230441893
• Report Number: 1644487-2021-00164
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 03/25/2021

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: 10/27/2017
• Device Model Number: 106
• Device Lot Number: 4614
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR