MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems High impedance (1291); Failure to Deliver (2338)

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

Event Date 11/23/2013

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance.The physician declined to program off the device.Additional information was received that during an office visit on (b)(6) 2014, diagnostic results confirmed high impedance (impedance value >= 10,000 ohms) and that no stimulation was being delivered (output current ¿ 0 ma).No known interventions have occurred to date.No patient manipulation or trauma was reported.It is unknown if x-rays were taken or when the last normal diagnostic results were observed.

Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanted products have not been returned to the manufacturer to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Attempts for product return showed that the explanted devices were discarded after explant.Review of programming history showed that high impedance was first observed upon interrogation on (b)(6) 2014.Review of the decoder data indicates that the impedance value changed from 3119 ohms to 12965 ohms on (b)(6) 2013.Based on the information in the decoder, impedance was within normal limits at the time of implant and for about a month after implant.

Manufacturer Narrative

Analysis of programming history date of event, corrected data: review of available information shows that the change in impedance to high impedance occurred on (b)(6) 2013.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 3693199
• MDR Text Key: 4293352
• Report Number: 1644487-2014-00746
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2002
• Device Model Number: 300-20
• Device Lot Number: 845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2000
• 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: 39 YR