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

Model Number 102R

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 06/01/2012

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient was experiencing an increase in seizures during the summer of 2012.The patient¿s seizures did not change in type and were not continuous.The patient reported that summer heat was a potential trigger and did not have any health changes.The clinics notes indicate that the neurologist increased the device¿s normal mode and magnet mode output currents during an office visit on (b)(6) 2012; however, review of the available programming history showed that the patient¿s device was already programmed to those settings.Review of the available diagnostic history showed normal diagnostic results through (b)(6) 2011.Attempts for additional relevant information were made but have been unsuccessful to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• Brand Name: PULSE GEN MODEL 102R
• 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: 3754325
• MDR Text Key: 16802821
• Report Number: 1644487-2014-01027
• 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: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 102R
• Device Lot Number: 200776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2008
• 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: 47 YR