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

Model Number 106

Device Problems Image Display Error/Artifact (1304); Premature End-of-Life Indicator (1480); Invalid Sensing (2293); Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to a company representative that a surgeon reported a failure to detect a heart rate with two model 106 generators (the first generator has been reported in mfr report# 1644487-2016-01293).The patient had a successful pre-screening.It was determined that a sensitivity of 1 was appropriate.During the implant, the surgeon tried all the sensitivity settings and could only get ¿????¿, and a brief heartrate detection.The rate displayed for a few brief seconds before the ¿????¿ appeared again.The first generator was not implanted.A second generator was used and the surgeon reported that he had the same issues sensing the heartrate with the second generator.However, he elected to implant it and leave the autostimulation feature off.The surgeon reported no other difficulties communicating with the device and impedance upon diagnostics was within normal limits.Follow-up by the company representative to the patient¿s mother revealed that the device was still unable to sense the heartrate at the patient's first dosing session with the neurologist.Follow-up was received from the company representative after speaking with the surgeon further, the heartbeat sensing was reported to be ¿all over the place¿ and was providing wide ranges of numbers inconsistent with the baseline heartrate measured for the patient.The surgeon decided to place the device subpectoral to see if it worked.It was stated that it worked better in that location, but was still providing wide ranges of heartbeat detection that the surgeon considered unreliable.During surgery, the heartbeat was given 10 seconds to attempt to stabilize while detecting.Another 10 seconds after the detection would show asterisks, and another ten seconds it would show a wide range of numbers.A sensitivity level of 2 was tried and was better but did not resolve the issue.A troubleshooting appointment was scheduled for the patient¿s appointment on (b)(6) 2016.Another surface ecg was performed, and it was determined to use a sensitivity level of 3.It was noted that the r-wave detection reduces when the patient is laying down.Using software version 9.0, heartrate sensing was able to be achieved with no issues.Additional relevant information has not been received to-date.

Manufacturer Narrative

Additional details regarding the troubleshooting session were inadvertently not provided in the initial report.

Event Description

During the troubleshooting session on (b)(6) 2016, different sensitivity levels were attempted with version 11.0 software but the heartrate would return as "*****" then show as "?????" regardless of the sensitivity level selected.Then the device was interrogated and it was ensured the device was off with version 9.0 software.The pre-surgical evaluation indicated to use a sensitivity level of 4.It was attempted to use heartrate sensitivity levels of 4 and 5 but the difference between the baseline heartrate and the vns programmer was too high.Time was provided for the heartrate to level out and testing was repeated and adjusted the sensitivity to 3 with an acceptable difference of 0 to 1.The manufacturer's in-house programming history was reviewed, which provided settings and diagnostics for the date of 05/31/2016.

Manufacturer Narrative

Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event.Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the reporting number assigned for the actions for the reported event.

Event Description

Programming history review was performed (b)(4) 2018.Review of the patient's in-house programming history revealed data from (b)(4) 2016 (doi (b)(6) 2016) through (b)(4) 2018.The last programmed settings were 1.5/20/250/30/1.8/1.75/500/60/1.625/500/60.The last diagnostics test was 04/26/2018 with results of ok/ok/ok/3,270 ohms/ifi ¿ yes.No anomalies were noted in the review.A review of the downloaded data was performed.The results showed the device reached the 25% indicator on 08/09/2017 with a voltage of 2.840 volts, but the percentage of battery consumed was 13.654%.On the last date of available data, the percentage of battery consumed was 21.263% and the battery voltage was 2.605 indicating a low battery indicator was set.The data shows the device depleted prematurely.No other anomalies were noted in the review.Generator replacement surgery occurred.The explanted device was received.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The reported allegation of ¿undersensing delayed/intermittent heartbeat verification¿, was not duplicated.The pulse generator performed according to functional specifications.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.The pulse generator diagnostics were as expected for the programmed parameters.The reported premature end of life and end-of-service, was duplicated.Electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the low battery voltage.The data in the downloaded memory locations revealed that 22.500% of the battery had been consumed.With the pulse generator case removed and the battery still attached to the printed circuit board assembly, the battery measured 2.247 volts, confirming a low battery condition.The printed circuit board assembly was tested and results show that it failed several electrical tests.Fine grit sandpaper was used for the removal of the observed contaminates.After the trimmed edge of the printed circuit board assembly was cleaned, the electrical test was performed.Based on the electrical test results, the contamination that was observed on the trimmed edge of the printed circuit board assembly suggest probable electrical resistive paths were established between the copper edges on the trimmed edge.Remaining residual material on the printed circuit board assembly edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of specification) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegations of premature end of life.

Event Description

It was later reported that the patient¿s device is at a low battery status indicator and the physician believes it is premature because the patient is not set to high settings.The patient was referred for replacement due to the battery depletion.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5709146
• MDR Text Key: 48131004
• Report Number: 1644487-2016-01295
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2017
• Device Model Number: 106
• Device Lot Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z0280-2016
• Patient Sequence Number: 1
• Patient Age: 30 YR