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

Model Number 102

Device Problem Device Inoperable (1663)

Patient Problem Seizures (2063)

Event Date 07/01/2008

Event Type  malfunction  

Event Description

It was reported that the nurse suggested replacing the vns patient¿s device, but the patient¿s parent did not want the device touched at the time.The generator was previously programmed off.Additional information was received stating that the patient was programmed off prior to her visit with her neurologist in 2012.The patient¿s parent believed that vns was not helping the patient and that the patient¿s seizures were better without vns.In (b)(6) 2008, the neurologist discovered that the patient experienced a 50% decrease in seizure frequency during that summer although interrogation of the device at the time revealed the device was reportedly not working.The neurologist decided not to replace the device.The patient was referred for surgery to explant the device, but the surgeon decided that surgery could be dangerous and left the device implanted as it was not causing harm to the patient.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• 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: 3677785
• MDR Text Key: 4296083
• Report Number: 1644487-2014-00676
• 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: Physician
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2006
• Device Model Number: 102
• Device Lot Number: 11652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2004
• 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: 22 YR