MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Anxiety (2328); Depression (2361); Ambulation Difficulties (2544)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient that their vns was turned on in february and since then the patient has experienced worsening depression, anxiety, ambulation difficulties (difficulty getting out of bed and trouble driving), and suicidal ideations.The patient's output current was decreased from 1 ma to 0.5 ma.No additional relevant information has been received to date.

Event Description

Information was received that the patient has had the device turned off for about a month because he did not feel that it was working for him.He reports having severely increased depression and he is having an mri so he can have his vns turned back on to the lowest settings.The patient noted that the settings were increased however could not increase past 1 ma since his symptoms became worse.The patient now hopes to stabilize with tma and then restart vns to use it permanently.No additional relevant information has been received to date.

Event Description

After further review it was determined that the patient did not experience ambulation difficulties.

Manufacturer Narrative

F10.Adverse event problem (refer to coding manual) health effect - clinical code; corrected data: e2302 was inadvertently coded on the initial mdr.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11865577
• MDR Text Key: 252043139
• Report Number: 1644487-2021-00704
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 08/12/2021

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: 11/16/2022
• Device Model Number: 1000
• Device Lot Number: 205419
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/24/2021; 08/12/2021
• Supplement Dates FDA Received: 07/13/2021; 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR