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

Model Number 103

Device Problems Energy Output To Patient Tissue Incorrect (1209); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Aspiration/Inhalation (1725); Dyspnea (1816); Pneumonia (2011); No Code Available (3191)

Event Date 12/02/2014

Event Type  Injury  

Event Description

The patient's device was disabled due to the worsening of the patient's sleep apnea and breathing issues.A programming history review was performed and identified that the patient's device had been disabled on (b)(6) 2014.The most recent diagnostics from (b)(6) 2016 were normal.No further information has been obtained to date.

Event Description

The father of the patient reported also reported that the patient developed aspiration pneumonia which required having a feeding tube placed after the patient's vns was implanted.During the phone call the father reported that the patient's more recent breathing issues started 6 months ago when the family purchased a medical bed.The father believed that the vns and the medical bed were interacting causing the vns to fire resulting in the breathing issues.To mitigate the breathing issues the patient's the father placed a yoga mat between the patient and the bed in case there was any interaction between the devices causing the issue.The temporarily resolved the patient's breathing issues.The father based his conclusion that the vns was delivering current on the fact that the patient reached to their neck when the breathing issues occurred and an electrical tester that the father bought which indicated current was flowing when the father placed the tester on the patient's neck.The father also indicated the bed is putting out an electrical field/ magnetic field and the house has ¿tp links¿, which runs internet signal through electrical system which the father believes this may be a contributing factor.Settings from (b)(6) 2016 show that the patient¿s device was set to an output current of 0ma.The manufacturer of the medical bed was contacted and it was determined that the medical beds wireless remote operated in the frequency range of 315 hz which is well below the threshold where vns operates, 30khz to 100 khz.The father expressed desire to have the vns removed.The patient¿s vns was explanted on (b)(6) 2017.The explanted device has not been received to date.The surgeon who performed the explant indicated that he believed that the vns was not causing the patient¿s issues but he did not have definitive proof.No other relevant information has been received to date.

Event Description

The patient's neurologist stated that the patient was a very sick child and he did not believe that vns caused the aspiration pneumonia however he was not the treating physician at that time.No other relevant information has been received to date.The explanted product has not been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The patient's explanted lead and generator were received by the manufacturer.Product analysis is currently underway.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path.The device output signal was monitored for more than 24-hrs in a simulated body temperature environment.The pulse generator showed expected level of output currents and no signs of variation.Both interrogation and system diagnostic tests were performed.An electrical load was attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained.Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings.A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 2.999 volts during functional testing and showed an ifi=no battery status.The internal device data showed that 5.725% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Product analysis was completed on the returned lead portion.Note that the majority of the lead body - including the electrodes - was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, and no discontinuities were identified.There is no evidence to suggest an anomaly with the returned portion of the device.

Event Description

The patient's father reported that the patient would eat or take the bottle while implanted with vns.No additional or relevant information has been received.

• 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: 6240508
• MDR Text Key: 64441347
• Report Number: 1644487-2017-03000
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2015
• Device Model Number: 103
• Device Lot Number: 202954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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: 23 MO