MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Apnea (1720)

Event Date 09/26/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced apnea after a replacement when the newly implanted generator's settings were programmed to the settings on the previous generator.When this occurred, the patient started having apnea where she would stop breathing for 30 seconds at a time (same as on time).Once the patient's device was off and no longer providing stimulation she was able to breath like normal.This occurred while the patient was still in the operating room.The generator was then programmed off.The patient had no history of apnea.The patient later had the generator turned back on and titrated to lower settings.The patient has had no apnea since the return of stimulation.Per the physician, a combination of vns stimulation and anesthesia contributed to the apnea.The patient reportedly only had apnea at 3ma output current.After the cessation of anesthesia and turning the generator off, they were able to titrate the patient back to the lower settings without issue.

Manufacturer Narrative

Date of this report, corrected data: the initial report inadvertently listed 10/19/2018 as the submit date when it was 10/18/2018.

• Brand Name: PULSE GEN MODEL 106
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7981071
• MDR Text Key: 124208494
• Report Number: 1644487-2018-01855
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 10/19/2018

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: 08/12/2020
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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): Other
• Patient Age: 24 YR