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

Model Number 302-20

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

Patient Problem No Information (3190)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

The generator appears in the left abdominal area in an abnormal placement.

Manufacturer Narrative

The initial manufacturer report incorrectly stated that the x-rays showed normal placement of the generator in the upper left chest.The x-rays showed abnormal placement of the generator in the left abdominal area.

Event Description

It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms).The patient¿s device was subsequently programmed off.There was no change in the patient¿s seizure activity.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the upper left chest in a normal placement.The filter feed-through wires appeared to be intact.The lead connector pin was fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the x-rays images, the cause high lead impedance could not be determined.The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.During the procedure, it was noted that the electrode had visible damage right beyond the anchor tether.The explanting facility discarded the explanted products; therefore, no analysis can be performed.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Device manufacturing records and available programming and diagnostic history were reviewed.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure occurred, but did not cause or contribute to death or serious injury.

• 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: 3796059
• MDR Text Key: 4524773
• Report Number: 1644487-2014-01200
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

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: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 05/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2004
• 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: 22 YR