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

Model Number 302-20

Device Problems High impedance (1291); Appropriate Term/Code Not Available (3191)

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

Event Date 01/26/2014

Event Type  malfunction  

Event Description

The software flashcard was provided to the manufacturer for further review.Review of the decoder data showed normal lead impedance through (b)(4) 2013.The last 25% change in the impedance value was on (b)(4) 2014.High impedance was observed during an office visit on (b)(6) 2014.During the office visit, the patient¿s device settings were adjusted.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.Due to the orientation of the images provided, lead pin insertion cannot be assessed.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the high lead impedance remains unknown.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Additional information indicates that the date of event is (b)(6) 2014.

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that the patient recently experienced an electric shock injury which is believed to have caused the high impedance.It was reported that the patient would be referred for x-rays.The device was not programmed off after observing the high impedance.No additional relevant information has been received to date.No surgical intervention has been performed to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of 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

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

• Brand Name: PULSE GEN 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: 3816386
• MDR Text Key: 4677301
• Report Number: 1644487-2014-01307
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2010
• 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: 49 YR