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 Problems Chest Pain (1776); Seizures (2063); Neck Pain (2433)

Event Date 11/09/2016

Event Type  Injury  

Event Description

It was reported that a physician disabled a patient's generator because the patient was experiencing "too much chest wall pain with radiation into her left arm." the physician programmed the normal output current off, but left the magnet output programmed on.No additional intervention has been taken for the patient's pain.The painful stimulation started about a month prior to the report.Diagnostics were within normal limits at the patient's last two office visits.The patient's settings were adjusted at the last office visit, so the diagnostics were performed after the painful stimulation began.Later follow-up was received (b)(6) 2017 from the surgeon's office that the patient was referred by the neurologist for explant of the device as the patient seemed unwilling to accept the side effects.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Manufacturer Narrative

The incorrect patient code was inadvertently provided on the initial report.

Manufacturer Narrative

Corrected data: the type of report field was inadvertently not marked as ¿follow-up#¿1 on follow-up report#1.Corrected data: the date reported to manufacturer was inadvertently provided as 11/10/2017 on follow-up report #1 when it was intended to be provided as 12/05/2017.

Event Description

Information was received from the physician regarding the reported events.The patient¿s seizures did not worsen on vns, but instead the patient was a nonresponder to treatment.The patient reported pain in their chest at their last appointment, however the device was not disabled as the magnet mode has remained on.Surgery is likely but has not occurred to date.No additional information has been received.

Event Description

It was reported that the patient had pain in their chest wall and into their arm in 2017.The patient¿s generator was disabled.It was reported in clinic notes dated 11/27/2018 that the patient wanted vns explanted as it worsened her seizures.It was stated that the device was turned off in early 2018.She also stated that it causes pain and discomfort when her children accidentally hit it.Programming history was reviewed.The device had been programmed off at the end of 2016 and programmed back on in the beginning of 2017.No programming anomalies were seen.Surgery is likely but has not occurred to date.No further 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: 6996132
• MDR Text Key: 90868587
• Report Number: 1644487-2017-04716
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2017
• Device Model Number: 106
• Device Lot Number: 203808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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): Required Intervention
• Patient Age: 21 YR