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

Model Number 105

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

Follow-up with the treating physician revealed that device was interrogated on (b)(6) 2014 but system diagnostic test was not documented in the patient's notes.

Event Description

It was reported that high impedance was observed on system diagnostics testing.The patient was referred for replacement surgery.Clinic notes dated (b)(6) 2015 reported increase in the patient's seizure frequency and behavioral disturbances.There were no other modifying factors or associated symptoms.The mother reported that the patient's baseline seizure frequency had been about 1-2 times per week and since doubled.The patient's pre-vns seizure frequency rate was approximately 11-30 seizures per month.During surgery on (b)(6) 2014, the cause of the high impedance was determined to be due to incomplete lead pin insertion into the generator header.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 105
• 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: 4530216
• MDR Text Key: 5506745
• Report Number: 1644487-2015-03889
• 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,Followup
• Report Date: 01/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 105
• Device Lot Number: 202828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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): Required Intervention
• Patient Age: 10 YR