MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 06/27/2011

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011.The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types.The episodes involved the patient chewing his tongue and losing consciousness.The patient was sleepier and more confused during the post ictal period.Since hospitalization, the patient had 1-2 seizures.Attempts for additional relevant information have been unsuccessful to date.

Event Description

On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.

• Brand Name: PULSE GEN MODEL 103
• 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: 3942259
• MDR Text Key: 4574636
• Report Number: 1644487-2014-01822
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: 103
• Device Lot Number: 2419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2009
• 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 Outcome(s): Hospitalization
• Patient Age: 31 YR