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 Ambulation Difficulties (2544); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after patient last surgery the physician did not program generator.The patient was taken to the hospital after due to constant stimulation from the device.The patient was unable to walk, eat, and speak due to stimulation.The patient went to neurologist and had the settings decreased and returned to baseline.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected age at time of event, initial report: inadvertently listed wrong age corrected date of event, initial report: inadvertently listed wrong date.

Event Description

Physician stated he was not aware that an event occurred.He had nothing in his chart indicating this event took place.He saw him in clinic recently and interrogated his device.Vns was at normal battery.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15089447
• MDR Text Key: 296459902
• Report Number: 1644487-2022-00894
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: 09/25/2019
• Device Model Number: 1000
• Device Lot Number: 204266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male