MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Event Date 12/29/2014

Event Type  Injury  

Event Description

It was reported that following generator replacement the patient device settings were increased and the patient did not vocalize much since the titration.It was reported that the patient was previously non-verbal, but was now non-vocal which is abnormal for the patient.There was question as to whether or not the patient was experiencing vocal cord paralysis.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Additional information was received from the patient's treating physician.On (b)(6) 2014 his signal frequency was increased from 20 to 30hz and pulse width to 500 usec from 250.(he had tolerated these settings with his initial generator prior to battery depletion or replacement).The patient's therapy was lowered from signal frequency to 20hz and pulsewidth to 250 usec and the patient had immediate return of spontaneous vocalization.

Manufacturer Narrative

Manufacturer Narrative

Event date corrected data to (b)(6) 2014.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4495824
• MDR Text Key: 5350222
• Report Number: 1644487-2015-03791
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2010
• 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): Other
• Patient Age: 10 YR