MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem High impedance (1291)

Patient Problems Chest Pain (1776); No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.

Event Description

It was reported that high impedance was detected on the patient's generator and the generator output currents were subsequently turned off.While the patient's vns generator was intentionally disabled due to high impedance, the patient experienced an increase in seizure frequency.It was reported that the patient had scratched their neck, no other known trauma or manipulation has occurred to date.The patient did not experience any known adverse events or pain associated with the high impedance.The patient had x-rays performed, and per the physician, there were no abnormalities shown on the patient's x-rays.A review of the device history records for the generator showed that the generator passed all quality tests and functional specifications prior to distribution.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.As indicated in the physician's manual, high lead impedance (>/= 5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction.Additional investigation is underway.No relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Ap and lateral neck x-rays were received and reviewed.The entire generator was not included within the scope of the image and therefore no assessment could be made regarding the connector pin, feedthru wires and portions of the lead routed behind the generator.The generator appeared to be placed in the upper left chest per labeling.Strain relief was not present per labeling as a strain relief bend appeared to be present; however, no strain relief.There were no sharp angles, discontinuities or causes of high impedance in the images provided.Based on the quality and scope of the images provided, there was no obvious for cause for high impedance detected.The presence of a microfracture could not be ruled out in the visible portion of the lead and an assessment could not be made on the nonvisible portions of the lead.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced due to the higher impedance for model 1000 generators compared to those reported by model 103-106 generators.The generator lead impedance was within normal limits on the date of the replacement.The family reportedly opted to have the generator replaced.The explanted generator has not been received by the manufacturer for product analysis to date.No further relevant information has been received to date.

Event Description

The patient's surgeon replied to the m1000 field action notification with a results report from ap and lateral chest x-rays.The reason and clinical indication for the x-rays was indicated as "chest pain." the finding of the x-rays reported "the heart was not enlarged.The lungs are clear of infiltrates.Pacemaker is noted with the lead extending up to the neck.Degenerative changes noted in the spin." the pacemaker noted in the x-rays was likely referring to the patient's vns generator and leads.The impression of the x-rays was noted as "stable chest." multiple attempts were made to obtain the physician's assessment regarding the relationship between the chest pain and the vns; however, no further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8539871
• MDR Text Key: 142771252
• Report Number: 1644487-2019-00762
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2020
• Device Model Number: 1000
• Device Lot Number: 204700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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: 47 YR