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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Sore Throat (2396)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).

Event Description

It was reported that a patient, recently implanted with vns, had side effects: a very trembling voice, sore throat and tingling sensations.It was reported that the device settings (frequency and pulse width) were modified due to those side effects, without success.It was reported that the patient has never had this event prior vns implantation.Programming history of the patient's device was provided to the manufacturer for review.It appears that on (b)(6) 2016, the device was programmed at output current 0.75ma, pulse width 250-sec, frequency 20hz, on time 30sec and off time 5min.The device system diagnostic test was not performed.Additional information was received from the physician, indicating that the patient was implanted on (b)(6) 2016.The adverse events began when vns was turned on, on the implant date.It was reported that the patient started to have pain when the output current of 1ma was reached.This occurs during the on time, never during the off time.It was also reported that the voice alteration occurs whatever the output current value was, and during only the on time.The patient will be seen in clinic in mid-(b)(6).The impedance will be tested.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.No additional information was provided to date.

Event Description

Further information was received indicating that the patient was seen by the physician on (b)(6) 2016.It was reported that the patient was doing well; the reported events have stopped.It was reported that the physician decided to increase the output current from 0.75ma to 1ma.The device was tested and system diagnostics returned impedance results within normal limits with 3401 ohms.

• Brand Name: PULSE GEN MODEL 103
• 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: 5566664
• MDR Text Key: 42412419
• Report Number: 1644487-2016-00761
• 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,Followup
• Report Date: 03/16/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 103
• Device Lot Number: 300292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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: 32 YR