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 Problem No Code Available (3191)

Event Date 03/09/2010

Event Type  Injury  

Event Description

It was reported by the patient to case management that they wanted to have their vns taken out and that they had called their surgeon but had not been referred there.Information was later received that the patient¿s explant would not be covered under their insurance plan and patient would have to pay out of pocket therefore the patient was given the option of just disabling their vns device.Additional information was received from the patient's psychiatrist during follow-up that the patient had their device explanted due to lack of efficacy and hoarseness.Per the physician, the patient returned to the surgeon to have vns removed and was considering getting ect.No additional relevant information has been received to date.

Event Description

Information was received that the patient's device was never explanted and is still implanted.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: 9371447
• MDR Text Key: 167869028
• Report Number: 1644487-2019-02304
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 07/02/2021

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: 06/07/2007
• Device Model Number: 102
• Device Lot Number: 013476
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR