MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Chest Pain (1776); Undesired Nerve Stimulation (1980); Neck Pain (2433); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient's vns battery had depleted quickly from approximately 80% to 25 or 30%, though, no timeframe was provided.It was also reported that the patient felt pain around the electrodes, which was resolved when the patient taped the magnet over her generator.The patient also felt constant pain around her generator and tenderness.The physician observed no swelling or redness.There was no trauma to the area nor migration of the generator.The patient also stated that she felt as if the device was constantly going off.However, the autostim was reported as being disabled.Diagnostics were reported to be within normal limits.The doctor was considering x-rays to determine if there was a intermittent problem that wasn't detected with diagnostics.X-rays have not been reviewed by the manufacturer to date.A review of device history records was performed and revealed that the generator passed quality control inspection prior to distribution.The tablet data for the generator was received and reviewed by the manufacturer.Only data from the day of the report was received and showed that the battery voltage was in the 25% range.However, based on the percent value of the battery capacity used, the battery voltage is lower than expected.An internal investigation was completed on premature battery depletion events.The results of the investigation 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.Revision surgery was scheduled for the patient due to the low battery status and it was reported that the physician believed the pain to be associated with the low battery.However, no surgery is known to have occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently had selected adverse event.However, these events are being reported in mfg.Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report.Outcomes attributed to adverse event, corrected data: initial report inadvertently had selected required intervention to prevent permanent impairment/damage.However, these events are being reported in mfg.Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report.Describe event or problem, corrected data: initial report inadvertently reported pain around the generator, undesired stimulation, and painful stimulation in the neck.However, these events are being reported in mfg.Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report.(b)(4).However, these events are being reported in mfg.Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report.

Event Description

It was reported that the patient was being referred for full vns revision surgery as the patient had been having headaches in addition to the pain and stimulation related events which are captured in mfg.Report #1644487-2017-04265.These events, which were previously reported in this mfg.Report, #1644487-2017-04099, are now captured in mfg.Report, #1644487-2017-04265 as they are unrelated to the battery depletion captured in this mfg.Report.It was reported that the battery indicator was showing 25%.The patient's vns was programmed off.The full vns revision surgery was completed.The explanted generator and lead have not been received by the manufacturer to date.

Event Description

It was reported that the explanted devices had been discarded.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6691096
• MDR Text Key: 79235672
• Report Number: 1644487-2017-04099
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 08/14/2017
• Supplement Dates FDA Received: 08/08/2017; 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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