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

Model Number 302-20

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 09/05/2012

Event Type  malfunction  

Event Description

Clinic notes dated (b)(6) 2013 were received which indicate that while the patient was under the care of his previous physician, the lead wire of the vns broke and the device stopped functioning because of this.Per the notes, "it has never been determined to put it back".Notes dated (b)(6) 2012, indicate the patient has one to two seizures which are small every seven days.The physician states that he will discuss if there is benefit in starting the vns treatment.The patient's vns device had been previously explanted with no replacement, and therefore the clinic notes were sent because the patient was considering getting implanted with vns again.Product analysis of the explanted generator and lead indicated that the generator depletion was an expected event as determined by a battery life calculation and the battery voltage measurement.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the generator.A significant portion of the lead was not returned; only about 11 cm of lead was returned.Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.The lead explant had been prophylactic per the surgeon.The operative notes were received, dated (b)(6) 2012, which indicate that upon inspection of the lead, the lead sheath appeared to be intact.However, there was fluid density within the lead consistent with a break in the sheath at some point.Given this potential lead break, the surgeon did not replace the generator and severed the lead at the generator, leaving the remaining lead in the body.Per programming history, system diagnostics were within normal limits in (b)(6) 2011 and the returned portion of the device had no anomalies per product analysis.No other information has been provided.

Event Description

Notes from (b)(6) 2015 reported that after the battery depleted and the leads fractures, the patient did not want vns replaced at that time.Reimplant has not occurred to date.

Manufacturer Narrative

Only a portion of the device was returned for analysis, which found no anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a 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: 3563168
• MDR Text Key: 4059872
• Report Number: 1644487-2014-00134
• 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
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2010
• Device Model Number: 302-20
• Device Lot Number: 200421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2012
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2010
• 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: 20 YR