MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported by a physician that a patient's device was leaking current from the generator or the wire had come loose because the patient was feeling a strange sensation at the generator site.The patient had been feeling the sensation for a long time, and it only occurred during stimulation.The physician decreased the output current from 1.5ma to 0.75ma, and the sensation went away.Diagnostics were not performed.The physician then decided to refer the patient for generator replacement and/or lead replacement surgery and ordered x-rays.No further relevant information has been received to date, and no surgical intervention has occurred to date.

Event Description

The patient experienced shock-like sensations near his generator in certain positions.Diagnostics were performed, which showed high impedance.No surgical intervention has occurred to date.

Event Description

The patient had generator replacement surgery only.Diagnostics in pre-op were within normal limits.The patient's lead was not replaced, and diagnostics were also within normal limits after the generator was replaced.The hospital does not return product to the manufacturer.Therefore, no analysis could be performed.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• 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: 5751547
• MDR Text Key: 48239025
• Report Number: 1644487-2016-01441
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 303-20
• Device Lot Number: 201731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2011
• 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): Other
• Patient Age: 47 YR