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

Model Number 103

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 05/10/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was hospitalized on (b)(6) 2014 due to an increase in seizures.The patient was seizure free for some time but began experiencing breakthrough seizures four months ago.The patient¿s device was tested and diagnostic results showed normal device function.The patient had not been taking her medication and it was noted that the patient¿s parent may not be providing effective oversight of the patient¿s treatment.The patient¿s medication noncompliance was believed to may be related to the increase in seizures.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 4163583
• MDR Text Key: 4871461
• Report Number: 1644487-2014-02634
• 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: 09/16/2014

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: 12/31/2012
• Device Model Number: 103
• Device Lot Number: 2927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2011
• 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: 27 YR