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

Model Number 7103

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/11/2020

Event Type  Injury  

Event Description

It was reported that the patient was initially experiencing 'hypotonia' that was "possibly related" to the vitaria implant procedure.Information was received that the patient was experiencing "low blood pressure" (hypotension).The severity was noted to be "severe".It was stated that it is "possibly related" to the vitaria implant, with rationale "at the second day the subject has had an transitoric unspecified fever and symptoms of diarrhea after implantation.Low blood pressure was registered continuously.Infusion of noradrenalin and dopamine was performed." and not related to vitaria stimulation.There was no action taken with the study treatment, medication and prolonged hospitalization was required as treatment, and the patient has recovered.No additional relevant information has been received to date.

• Brand Name: PULSE 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11148527
• MDR Text Key: 226081296
• Report Number: 1644487-2021-00055
• 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,foreig
• Type of Report: Initial
• Report Date: 01/11/2021

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 Model Number: 7103
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 01/11/2021
• 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): Required Intervention