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

Model Number 104

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Seizures (2063)

Event Date 02/22/2014

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient was admitted to the hospital on (b)(6) 2014 due status epilepticus.The patient had several seizures that day and was treated with medications.The physician stated that there was no clear precipitating factor but notes that the patient has a history of pseudoseizures and has been noncompliant with medications in the past.Ct did not show any acute lesion.Chemistry panel and complete blood count (cbc) blood test were both within normal limits.The patient did not have any seizures during her hospitalization.The patient was discharged on (b)(6) 2014.The patient had a follow-up visit with the neurologist on (b)(6) 2014.The patient did not have any seizures since her hospitalization.The patient¿s device was tested and diagnostic results revealed an ifi condition.Attempts for additional relevant information were made but have been unsuccessful to date.

• 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: 3727840
• MDR Text Key: 4327088
• Report Number: 1644487-2014-00900
• 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: 03/11/2014

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: 10/31/2011
• Device Model Number: 104
• Device Lot Number: 201296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2009
• 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; Required Intervention
• Patient Age: 31 YR