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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

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

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there were some heartbeat detection issues experienced during the patient's (b)(6) 2015 implant surgery.An m106 device was only intermittent detecting the correct heart rate for the patient, even after following troubleshooting which involved nerve irrigation and moving the device in multiple different locations among other steps (reported in mfr.Report # 1644487-2015-06369).At this point, a new m106 device was used but troubleshooting proved unsuccessful to detect heart rate with this as well.This device was implanted in the patient despite not being able to sense the heart rate at any sensitivity level.Review of programming history shows data from the implant date (b)(6) 2015.All output currents remained programmed off for the duration of surgery, except for the final diagnostics and interrogation.Diagnostics were within normal limits (3097 ohms and 3098 ohms).In the course of surgery, sensitivity settings 1-5 were attempted, but foreground heart rate could only be obtained for settings 1, 3, and 4.

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 recall reporting number assigned for the actions for the reported event.

Event Description

As a part of the field action, a company representative performed heartbeat testing for the patient's device with the permission of the physician.The patient's heart rate was verified to be detected by the generator at both seated and standing at a sensitivity setting of 1.

Event Description

It was reported that the generator had reached 25%.During an office visit the heartbeat verification was attempted however the patient's heartbeat could not be detected.The patient was then referred for a generator replacement due to the battery depletion.The generator was later replaced and has not been received to date.The internal programming history database was reviewed and found data for the generator.Review of the data confirmed that the generator was depleting prematurely.It was identified through an internal investigation that the observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths.This finding is indicative that the generator will reach true end of service earlier than expected.A secondary cause for premature 25% battery life indicators in a small subset of associated generators may be high beginning of life (bol) battery impedance.Generators only affected by this secondary root cause would be expected to rebound back to normal battery life levels without substantial programming changes.

Event Description

The explanted generator was received and is currently pending analysis.

Event Description

Analysis was completed on the explanted generator.Upon receipt it was found that the battery indicator was ifi = no.The generator initially failed testing of the heartbeat sensing feature as well as some electrical testing.The generator case was opened and the printed circuit board assembly (pcba) was evaluated.It was noted that there were contaminates on the trimmed edge of the pcba.The contaminates were then removed and sensing testing was performed again.The device performed to functional specification during the test of the sensing function.Based on the results of analysis it appears that the reason for the premature battery depletion and undersensing issues are related to the contaminants that were left on the pcba during manufacturing.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5209729
• MDR Text Key: 31080057
• Report Number: 1644487-2015-06343
• 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,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2017
• Device Model Number: 106
• Device Lot Number: 4374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/08/2015
• Supplement Dates Manufacturer Received: Not provided; 06/29/2017; 08/31/2017; 10/03/2017
• Supplement Dates FDA Received: 12/01/2015; 07/24/2017; 09/20/2017; 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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: 7 YR