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

Model Number 302-20

Device Problems High impedance (1291); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2016

Event Type  malfunction  

Event Description

It was reported that a patient's device had high impedance and was not delivering the intended output current, which was identified through system diagnostics.Diagnostics were within normal limits in (b)(6) 2016.The physician left the patient's device programmed on since the patient was not experiencing discomfort.X-rays were taken, but were not reviewed by the manufacturer to date.No known surgical intervention has occurred to date.

Event Description

X-rays were reviewed by the facility.The lead was difficult to visualize, but the visible portion of the lead appeared intact.No known surgery has occurred to date.

Event Description

The patient had full revision surgery.The reported reason for the surgery was due to battery depletion.The explanted generator was received, but analysis has not been approved to date.The explanted lead was not returned to the manufacturer.No further relevant information has been received to date.

Event Description

Analysis of the generator was approved.The battery voltage was 3.143 volts (not at ifi) as measured during the final electrical test.The data in memory locations revealed that 4.404% of the battery had been consumed.Electrical test results showed that the pulse generator performed according to functional specifications.Results of diagnostic testing indicated the device was operating properly when tested with various load resistors.There were no adverse functional, mechanical, or visual issues identified with the returned generator.The data downloaded from the generator showed that the most recent change in impedance was on the date of explant which was from 4174ohms (within normal limits) to 18576ohms (high impedance).This indicates that the patient's device was most likely having intermittent high impedance.No further relevant information has been received 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: 6168716
• MDR Text Key: 62602842
• Report Number: 1644487-2016-02845
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2017

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: 07/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2017; 03/11/2017; 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2005
• 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: 58 YR