MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 03/10/2010

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2013 indicated that at the age of (b)(6), the patient started experiencing a second type of seizure that was different from the usual ones.They were of an unknown etiology factor, last approximately 1 minute, occurring 2 to 3 per day, and occur when awake.The patient becomes completely unresponsive, loses awareness, eyes are staring.No automatisms, no stiffening posturing, no tongue or cheek bites, no incontinence.Patient has falling secondary to the seizures.The relationship of the new seizures to vns has been unsuccessful to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Previously submitted mdr inadvertently did not provide the correct product information for the suspect device involved in the event.

Event Description

Additional information was received stating that the vns patient¿s seizures were milder after device settings were increased and the patient¿s change in seizure pattern is expected for vns responders.The patient¿s device was tested and showed normal device function.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4008513
• MDR Text Key: 4778752
• Report Number: 1644487-2014-02020
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Model Number: 102R
• Device Lot Number: 200746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2008
• 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: 45 YR