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

Model Number 102

Device Problems Improper or Incorrect Procedure or Method (2017); Cut In Material (2454)

Patient Problem Seizures (2063)

Event Date 09/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 it was reported through clinic notes dated (b)(6) 2014 that the patient has had some worsened feeling of absence type seizures.It was noted that diagnostics showed normal results.The physician stated that it is difficult to know clinically if her epilepsy is really losing control.The patient underwent a full revision surgery due to end of service and surgeon error due to lead being cut by the surgeon.The explanted products were discarded by the hospital and therefore cannot be returned for product analysis.Good faith attempts for further information from the physician have been unsuccessful.

• Brand Name: PULSE GEN MODEL 102
• 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: 4286007
• MDR Text Key: 5300299
• Report Number: 1644487-2014-03171
• 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: 11/06/2014

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: 07/31/2008
• Device Model Number: 102
• Device Lot Number: 016030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2006
• 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): Other
• Patient Age: 37 YR