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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 10/28/2015

Event Type  malfunction  

Event Description

A report was received indicating that a patient's device was exhibiting high lead impedance.X-rays were ordered and there was indication that the patient may undergo full system revision.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

X-rays were submitted to the manufacturer for evaluation.The x-rays did not reveal any gross fractures, discontinuities, or sharp angles in the portion of the lead that could be assessed.A portion of the lead was not visible on the x-rays and therefore could not be evaluated.A definitive cause for the high impedance could not be determined from the images provided and the presence of a microfracture could not be excluded.The patient's treating neurologist indicated that the high impedance was measured via system diagnostics from the device on (b)(6) 2015 and that the device output was disabled on that date.The patient was referred for surgical consult and the surgeon indicated he planned to evaluate the generator pin connection first and then perform a full system revision if necessary.Surgery is likely but has not occurred to date.

Event Description

The patient underwent successful generator lead explant and replacement on (b)(6) 2016.No visual anomalies were reported regarding the generator pin connection or the lead body.An implant card received indicated the reason for replacement to be lead discontinuity.The physician noted scar tissue on the nerve in the location of the former lead electrodes but was able to successfully remove the former electrodes and place the new electrodes in the same area.Impedance measurements were normal.The explanted generator and lead were discarded by the explanting hospital.

• Brand Name: LEAD MODEL 302
• 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: 5245902
• MDR Text Key: 32251563
• Report Number: 1644487-2015-06501
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

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: 11/30/2004
• Device Model Number: 302-20
• Device Lot Number: 7416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2016; 01/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2002
• 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: 36 YR