MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

An implant card was received providing the vns patient¿s product information.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

It was reported that the vns patient was experiencing an increase in seizures.The patient has myoclonic jerking and is known to over report.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 3918484
• MDR Text Key: 4606609
• Report Number: 1644487-2014-01716
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2011
• Device Model Number: 104
• Device Lot Number: 201043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2009
• 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: 52 YR