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

Model Number 102

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

Patient Problem Seizures (2063)

Event Date 01/05/2015

Event Type  Injury  

Event Description

It was reported that the vns patient had six seizures in one week in 25 minutes and that the magnet was not aborting the seizures.The patient was subsequently admitted to the hospital.The patient was reported to have a uti and a high intake in soda which may have triggered the seizures.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2007.A battery life calculation using the available programming history showed approximately 2.6 years remaining.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• 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: 4485095
• MDR Text Key: 5568539
• Report Number: 1644487-2015-03755
• 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
• Report Date: 01/12/2015

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: 08/30/2008
• Device Model Number: 102
• Device Lot Number: 016158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2006
• 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): Hospitalization
• Patient Age: 33 YR