MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Nausea (1970); Vomiting (2144); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes were received for patient referral for replacement.Notes indicated the reason for referral was due to low battery.They also indicated that the mother reports the patient has had a dry cough from vns and the mother wanted the battery checked because of this.The mother also reported that since november about every three weeks the patient has gi upset leading to vomiting or stomach ache.The patient was put on prilosec and this has helped a bit.Notes state he is now having side effects including coughing when the device fires and perhaps some gi issues and painful at times.It is unclear if the patient's referral for replacement is related to the adverse events he has been experiencing.No additional information has been received to date.Surgery has not occurred to date.

Event Description

Information was received that the patient underwent a prophylactic generator replacement.The hospital discarded the explanted devices and it is not available for return.

• Brand Name: PULSE GEN MODEL 105
• 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: 8554701
• MDR Text Key: 143225355
• Report Number: 1644487-2019-00795
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

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: 10/28/2015
• Device Model Number: 105
• Device Lot Number: 3797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• 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: 26 YR