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

Model Number 102R

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing an increase in seizures and had an office visit on (b)(6) 2015.Follow-up with the physician¿s office revealed that the increase in seizures was due to the improper use of the magnet by the patient¿s nursing home.When attempting to activate magnet mode stimulation, the nursing home was placing the magnet over the device and temporarily disabling the intended therapy.No issues were suspected with the device itself.

Event Description

Follow-up with the nursing home revealed that the vns patient was sleeping with the magnet on a wrist strap, which is believed to the have caused temporary device disablements.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102R
• 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: 4789429
• MDR Text Key: 5802197
• Report Number: 1644487-2015-04766
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2009
• Device Model Number: 102R
• Device Lot Number: 200677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2007
• 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 Age: 52 YR