MAUDE Adverse Event Report: LIVANOVA USA, INC. VITARIA GEN MODEL 7103; GENERATOR

Model Number 7103

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

Patient Problems Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that a patient was experiencing an adverse event of acute hypoxic hypercarbic respiratory failure that was noted to be definitely related to the vitaria implant:.The outcome of the event was noted to be not recovered/not resolved.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient could not keep extubated status post vns implant.The patient experienced acute hypercarbic respiratory failure upon extubation and had to be re-intubated and sent to the micu.The outcome was noted to be recovered/resolved.

Event Description

Additional information was received about the reported event.It was noted that after getting the device implanted on (b)(6) 2022 the patient experienced acute pulmonary edema and was hospitalized and then discharged on (b)(6) 2022.Post vitaria implantation procedure, the subject experienced acute hypercarbic respiratory failure and was hypoxic.Prior to the procedure the subject was in his usual state of health (usoh) and had no complications during the procedure.The subject was somewhat tired.The decision was made to reintubate and he was transferred to micu for further management.A chest x-ray prior to re-intubation showed bilateral infiltrates concerning for (c/f) pulmonary edema.The investigator assessed the event of acute pulmonary edema as definitely related to vitaria implant (could not keep extubated status post vitaria implant), not related to vitaria system stimulation, not related to vitaria system other, not related to other study procedure, and definitely related to the subject¿s underlying disease (hfref, copd, iv fluids given intra-operatively, and sedation).

• Brand Name: VITARIA GEN MODEL 7103
• 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: 14052826
• MDR Text Key: 288878186
• Report Number: 1644487-2022-00406
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

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 Model Number: 7103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 06/06/2022; 08/23/2022
• Supplement Dates FDA Received: 07/05/2022; 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male