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

Model Number 106

Device Problem No Display/Image (1183)

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

Event Date 04/13/2018

Event Type  malfunction  

Event Description

It was reported that a patient's generator displayed the 25% battery life remaining indicator upon interrogation during a clinic visit and may have possibly reached the intensified follow-up indicator.It was later reported that the patient's generator displayed the 75% battery life remaining indicator during a clinic visit 1 month later.No additional relevant information has been received to date.No relevant surgical intervention has occurred to date.

Event Description

Programming history from the second clinic visit was reviewed for the patient's device and revealed that 31% of the battery capacity had been consumed to date.This indicated that a 50-75% life remaining indicator was observed during the second visit.No additional relevant information has been received to date.

Event Description

Information was now received that the patient's device has been explanted and replaced reportedly due to prophylactic replacement.The patient's replacement surgery facility is a no return site therefore generator has not been received into analysis to date.No additional relevant information has been received to date.

• 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: 7574594
• MDR Text Key: 110364784
• Report Number: 1644487-2018-00972
• 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 Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2017
• Device Model Number: 106
• Device Lot Number: 203634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 11/29/2019
• Supplement Dates FDA Received: 08/06/2018; 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 36 YR