MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551)

Event Date 10/24/2019

Event Type  Injury  

Event Description

Physician reported that the patient presented with bradycardia, hypotension, and confusion episodes.The patient was admitted to the hospital.The cardiologist at the hospital felt that the vns may be contributing to the patients symptoms.No other relevant information has been received to date.

Event Description

Information was received from the physician noting that the it is unknown if the vns contributed to the reported bradycardia, hypotension and confusion episodes.The patient was dehydrated and the egg showed new incomplete right bundle branch block.The physicians office did not have referral from the hospital; however, per the patient, they were weak, confused and dehydrated.The patient was referred to cardiology for follow-up.No intervention was noted to have been taken.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 9336973
• MDR Text Key: 166846673
• Report Number: 1644487-2019-02230
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2019
• Device Model Number: 104
• Device Lot Number: 204336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/09/2020
• 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): Hospitalization
• Patient Age: 51 YR