MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 08/22/2014

Event Type  Injury  

Event Description

The patient began experiencing painful stimulation in the throat on (b)(6) 2015.Diagnostic results were checked and within normal limits.The patient did not experience any trauma or manipulation that may have contributed.On 06/16/2015 the patient reported that he is planned to have his vns removed and he had a consultation that day in which the physician agreed to the removal.The patient noted that he was planning to have the device removed due to being unable to breathe associated with stimulation.He also has coughing and throat pain associated with vns stimulation.He noted that his diagnostic results, both systems and normal were fine and within range.Follow-up with the physician was unclear on whether the explant is for patient comfort or to preclude a serious injury.Further attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received on 07/16/2015 from the physician's office.The nurse indicated that the patient's generator was disabled a couple of months prior due to the throat pain he was experiencing.No recent diagnostics were available to provide but it was stated that the device was functioning normally a few months ago.The plan for the patient is to keep the device disabled and try to get him set up for removal of the device although this is not planned to date.She said that the disablement and surgery is both for comfort and to possibly prevent a serious injury from the pain.The patient complained of severe pain in the throat area with stimulation.

Event Description

New information was received that the patient¿s device was explanted at least 2 years prior.It was stated that the patient did not need the vns device and is now doing well.No additional information has been received to date.The explanted device has not been received for analysis to date.

Event Description

Additional information was received that the generator was turned off.

• Brand Name: PULSE GEN MODEL 102
• 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: 4919084
• MDR Text Key: 6436845
• Report Number: 1644487-2015-05208
• 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: Consumer,Health Professional,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2019

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: 02/29/2008
• Device Model Number: 102
• Device Lot Number: 015227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/16/2015
• Supplement Dates Manufacturer Received: Not provided; 10/24/2019; 11/25/2019
• Supplement Dates FDA Received: 07/31/2015; 11/18/2019; 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2006
• 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: 51 YR