MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 01/06/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient reported tha ther surgeon told her the neurologist observed high lead impedance the day before while communicating with the vns device.The surgeon said that he reviewed x-rays and there did not seem to be anything wrong with the device.The patient stated that the vns device was turned on (b)(6) 2013, and she was seen yesterday ((b)(6) 2014) when the high lead impedance was detected.No surgery was discussed as the physician did not believe there was an issue.The surgeon reported to the manufacturer on (b)(6) 2014, that he saw the patient earlier and did not believe there was any issue with the device because it was tested in the operating room multiple times and was within normal limits.On (b)(6) 2014, the patient reported that she had implant surgery 3 weeks ago and was in a lot of pain.The patient stated that she believed that the surgeon "cut a nerve".On (b)(6) 2014, the patient stated that she was still in pain and that she believed the device was not working.Ap and lateral chest and neck x-rays were sent to the manufacturer and reviewed.The connector pin appears to be fully inserted inside the connector block and the feedthru wires appear to be intact.The placement of the generator appears to be normal.A strain relief bend appears to be present; however a strain relief loop does not appear to be present.Two tie-downs appear to be present.A portion of the lead is behind the generator, and cannot be assessed.There appears to be no gross fractures, discontinuities or sharp angles in the portion of the lead that is visible.No other information has been provided.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: LEAD MODEL 304
• 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: 3600778
• MDR Text Key: 4154353
• Report Number: 1644487-2014-00324
• 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
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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: 55 YR