MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seizures (2063); Suffocation (2088); Discomfort (2330)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a vns patient, who is implanted since (b)(6) 2016, was not comfortable with vns.It was reported that when the physician tried to increase the output current from 0.25ma to 0.5ma, the patient had pain, suffocation, not really comfortable and crying.It was reported that the modification of the device parameters did not solve the issue.The event was described by the physician as serious ; the physician was looking to switch the device off and definitely explant it, but she finally decided to let it turned on at 0.25ma and see if there will be any improvement.It was reported that the device was tested on 05/25/2016 and system diagnostics returned impedance results within normal limits.It was reported that in beginning (b)(6) 2016, the device was turned off due to big seizures (high intensity than before vns implantation) but this was not related to vns at all.The device was then switched back on 1 month later, at the output current of 0.25ma.Review of manufacturing records confirmed all tests passed for the generator and lead prior to distribution.No additional information was provided to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5722569
• MDR Text Key: 47305480
• Report Number: 1644487-2016-01336
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 103
• Device Lot Number: 300289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2015
• 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: 31 YR