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 01/24/2019

Event Type  Injury  

Event Description

During generator and lead replacement surgery, it was reported that after diagnostics were performed it appeared as if the patient had stopped breathing.The patient would start breathing again after the diagnostic test was completed.The patient's device was programmed to zero for a long period of time prior to the replacement surgery.It was reported that the patient stopped breathing during every system diagnostic and that the anesthesia department noticed this during surgery.No other relevant information has been received to date.

Event Description

Further information was received confirming that the anesthesiologist was the one who noticed that the patient was not breathing during diagnostic testing.The diagnostic test was stopped for a minute and the patient's breathing returned to normal.A diagnostic test was performed again and the patient once again stopped breathing.A third attempt was made with the same result.The anesthesiologist stated that the event seemed to be related to vns.No other known intervention was performed as the patient resumed breathing after diagnostics were completed.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8340875
• MDR Text Key: 136185034
• Report Number: 1644487-2019-00307
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2020
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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: 44 YR