MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

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

Event Date 03/14/2019

Event Type  malfunction  

Event Description

It was reported that the patient believed that their vns generator battery depleted more quickly than expected.The patient had high programmed settings since implant.It was stated that tablet data from the implant surgery would not be obtainable as the tablet used was no longer available.The rep was asked to obtain the tablet data from the neurologist's tablet which interrogated the 18-25% battery life.It was further noted that the patient had 51 total magnet activations which may have contributed to the depletion.The rep stated that electrocautery was not used during implant.Data from the generator was reviewed, which indicated that the 18-25% battery status may have been related to beginning-of-life battery impedance leading to a false low battery warning.The battery voltage in these cases usually rebounds over time.However, further data has not been received for review so this case cannot be confirmed.Impedances were within normal limits.Device history records were reviewed an the device conformed to all specifications prior to distribution.No additional, relevant information was received to date.No known surgery has occurred to date.

Event Description

It was reported that the patient's generator was still showing 18-25% battery life when the patient was seen in the first part of (b)(6).Internal data from the generator was reviewed, and the battery voltage appeared to be depleting more quickly than the charge consumed.The battery voltage had not rebounded to date, not indicative of beginning-of-life battery impedance to date.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Clinic notes were received which indicated previous settings and diagnostic results from the patient's generator.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced due to battery depletion / prophylactic replacement.The explanting facility historically does not return explanted products; therefore, product return is not expected to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 8495088
• MDR Text Key: 141314845
• Report Number: 1644487-2019-00677
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2020
• Device Model Number: 104
• Device Lot Number: 204702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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 Age: 67 YR