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

Model Number 104

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 12/01/2013

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient was admitted to the hospital in (b)(6) 2013 for seven days for recurrent seizures.During hospitalization, the patient had 120 seizures that all came from the right parietal lobe and quickly spread.The patient¿s medications were subsequently changed.The notes also indicate that during an office visit on (b)(6) 2014, the patient had a few brief myoclonic seizures that lasted approximately a minute long.Attempts for additional relevant information were made but have been unsuccessful to date.

Manufacturer Narrative

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

• Brand Name: PULSE GEN MODEL 104
• 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: 3764725
• MDR Text Key: 4548599
• Report Number: 1644487-2014-01084
• 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: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Model Number: 104
• Device Lot Number: 20213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2012
• 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; Required Intervention
• Patient Age: 25 YR