MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Fatigue (1849)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was noted in clinic notes that the patient was feeling fatigue that the physician thought had a potential etiology in low generator battery.No additional information has been received to date.

Event Description

It was reported that the patient's generator was replaced.The hospital has a no-return policy for explants.The suspect product has not been received to date.No additional information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10576790
• MDR Text Key: 208288499
• Report Number: 1644487-2020-01283
• 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: 11/13/2020

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: 09/20/2019
• Device Model Number: 104
• Device Lot Number: 5500
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR