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

Model Number 106

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by nurse that the following message was received during vns system check on (b)(6) 2016: 'pulse generator is disabled due to a burst watch dog time out.Not supplying stimulation'.It was reported that the generator was programmed with an autostim output current which was equal to the magnet output current 2ma.System diagnostics test confirmed that the impedance value is normal.The nurse was advised to adjust vns system¿s settings programing the magnet output current higher than the autostim output current.Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution.

Event Description

After further investigations, no data from the clinic visit dated (b)(6) 2016 could be found saved on the site's sd card.Information was received that the patient is now being titrated back up after the event and is now at 1.5ma output current and the signal frequency was dropped from 30 to 20 hz.The vns system impedance is normal (2607 ohms).

• 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: 6157479
• MDR Text Key: 62380334
• Report Number: 1644487-2016-02818
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2017
• Device Model Number: 106
• Device Lot Number: 4536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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 Age: 21 YR