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

Model Number 302-20

Device Problems Break (1069); High impedance (1291)

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

Event Date 09/22/2013

Event Type  malfunction  

Event Description

It was reported that the patient underwent generator and lead replacement due to end of service and lead discontinuity.It was reported that the lead would not be sent back for analysis.It was reported that the device was programmed off after observing the high impedance.No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance.X-rays were sent to manufacturer for review.Review of x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out.The explanted generator was returned to manufacturer for analysis on (b)(4) 2014.Analysis of the generator was completed on (b)(4) 2014.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description

Review of the device decoder data showed that high impedance was first noted on (b)(6) 2013.The impedance changed from 2884 ohms to 10267 ohms.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Device manufacturing records were reviewed.X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Age at time of event, corrected data: additional information indicates that the patient was (b)(6) years old at the time of the event.Date of event, corrected data: additional information indicates that high impedance was first noted on (b)(4) 2013.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 3667134
• MDR Text Key: 4201662
• Report Number: 1644487-2014-00631
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2007
• 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: 10 YR