MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

It was reported that the patient underwent a surgery to move the patient's port to the opposite side from the vns.Prior to the procedure the patient's device was turned off and the battery status showed the 75% indicator.After the procedure, the device showed the neos battery status and a message was seen stating that output current was low.It was stated that bovie (electrocautery) was used during this port surgery.The patient later underwent a vns generator replacement surgery and it was found that the battery status was no longer depleted.System diagnostics at this replacement surgery were reported to be normal.The generator was replaced and has been received by the manufacturer.An analysis is underway but has not been completed to date a review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.No additional or relevant information has been received to date.

Manufacturer Narrative

Initial reporter; corrected data; initial mdr inadvertently submitted the incorrect initial reporter of the event.

Event Description

Analysis for the returned generator has been completed.The allegation of a premature end of life (eol) was not duplicated in the product analysis lab.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 2.965 volts during completion of the final electrical test and shows an ifi=no condition.A review of the internal memory of the generator revealed that 28.633% of the battery had been consumed.A review of the visual analysis for the generator revealed that burn marks were found on the generator¿s case indicating that the device may have been exposed to an electro-cautery tool at one point.There were no performance or any other type of adverse conditions found with the pulse generator.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8180656
• MDR Text Key: 130899731
• Report Number: 1644487-2018-02349
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 4291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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 Age: 19 YR