MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-30

Device Problem Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); No Code Available (3191)

Event Date 04/13/2010

Event Type  malfunction  

Event Description

It was reported that a patient had an increased perception of stimulation.The patient reported that her generator felt like it was stimulating stronger than normal and on some occasions not at all.Clinic notes stated that the patient was experiencing painful stimulation.The physician stated that the patient was randomly experiencing stimulation so painful that it made the patient's eyes water.The physician interrogated the patient's device and noted that the patient's battery life was fine.The physician adjusted the patient's settings in response to the reported adverse events.The physician did not suspect the lead is the cause of the patient's problems but still planned to evaluate the patient for a new device.The painful and erratic stimulation that the patient was experiencing may be related to a low impedance (dcdc 0) condition that was present intermittently throughout the available programming history.No additional relevant information has been provided to date.No surgical intervention has occurred to date.

Event Description

The patient underwent generator replacement surgery.Impedance was within the normal limits with the existing lead.The explanted generator has been received, but analysis has not been approved to date.No additional relevant information has been provided to date.

Event Description

Analysis was approved for the generator.The generator communicated normally when interrogated in its as-received condition.The eri flag was not set.The pulse generator diagnostics were as expected for the programmed parameters.The pulse generator performed according to functional specifications.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.No additional relevant information has been provided to date.

• Brand Name: LEAD MODEL 302
• 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: 6267805
• MDR Text Key: 65457624
• Report Number: 1644487-2017-03060
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2012
• Device Model Number: 302-30
• Device Lot Number: 201053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2009
• 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: 45 YR