MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Seizures (2063)

Event Date 01/01/2014

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for an increase in seizures that began the week prior.It was reported that the patient has experienced about 60 seizures over the past week.It is unknown if the increase in seizures was above the patient's pre-vns baseline frequency.It was reported that the patient was also experiencing painful stimulation at the electrode site that improves with pressure applied to the site.The physician decreased the patient's settings; however, this did not resolve the patient's pain.The device was later disabled.It was reported that device diagnostics were within normal limits (1326 ohms).The physician reported that he wanted to prophylactically replace the lead since it is 10 years old.X-rays were taken, but the results were not provided to manufacturer.It was reported that despite the diagnostics being within normal limits the physician still believes the painful stimulation and increase in seizures are due to a lead issue.It was reported that there was no trauma, medication changes or other recent changes that could have causes the increase in seizures and painful stimulation.Further follow-up revealed that the patient was airlifted to a hospital in a bigger city and it was decided to not replace the patient's lead.The patient's medication was adjusted and the vns was programmed back on and ramped up to 1ma output current.The physicians would not provide any additional information.

• Brand Name: PULSE GEN MODEL 105
• 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: 3606770
• MDR Text Key: 4161134
• Report Number: 1644487-2014-00347
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: 105
• Device Lot Number: 3207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2011
• 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; Other; Required Intervention
• Patient Age: 53 YR