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 Diarrhea (1811); Fatigue (1849); Weight Changes (2607)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing pretty significant weight loss and the physician wanted to see if this could occur with vns.Patient¿s weight had dropped from (b)(6) lbs to (b)(6) lbs.It was noted that the patient is developmentally delayed and is unable to verbalize if weight loss is related to loss of appetite or difficulty swallowing.It was noted that the patient also has diarrhea and seems tired all the time.No additional relevant information has been received to date.

Event Description

Additional information was received that the patient¿s symptoms of weight loss, diarrhea and fatigue have improved.Her weight was 107lbs at last visit ((b)(6) 2020) and 115lb in clinic on (b)(6) 2021.There have been no medication changes and no other known causes.The physician did mention it is odd patients grandmother verbalized issues with diarrhea and fatigue at the last appointment 12/11, however patient did not have testing done or diagnosis of other illness.Regarding the correlation of the symptoms with settings change, it was noted on (b)(6) 2019 to (b)(6) 2020 the patient lost 6 lbs.On (b)(6) 2020 patient weighed 140lb.(b)(6) 2020 , patient weighted 107.6lb.(b)(6) 2021 weight 115.6lb.Setting changes done (b)(6) 2020.Setting changes made to determine if it would affect patients weight.No additional 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
• MDR Report Key: 11055881
• MDR Text Key: 223152795
• Report Number: 1644487-2020-01733
• Device Sequence Number: 1
• Product Code: LYJ
• 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
• Report Date: 02/22/2021

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: 02/12/2020
• Device Model Number: 1000
• Device Lot Number: 204839
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR