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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Clinic notes were received on (b)(6) 2014.Clinic notes dated (b)(6) 2014 indicate that the patient was having starring spell seizures almost daily and that swiping the magnet stopped his seizures.The patient¿s vns showed high impedance.It was noted that the patient would be referred for x-rays and surgery.Clinic notes dated (b)(6) 2014 indicate that the patient had several small seizures and that he was doing well with seizure control until his trigeminal neuralgia started.The neurologist stated that once his trigeminal neuralgia pain is resolved he thinks his seizure frequency will return to baseline levels.

Event Description

On 12/08/2014 product analysis was completed on the lead.A portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot 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.Product analysis was completed on the generator on 12/11/2014.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2014, it was reported that high impedance was observed that day for the patient during a system diagnostics test.The patient was sent for a chest and neck x-ray and the device was disabled.The patient was referred for a full revision.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(4) 2014 it was reported that the patient was scheduled for a full revision surgery.Surgery took place on (b)(6) 2014.The explanted generator and lead were returned for product analysis on (b)(4) 2014.Product analysis is still underway and has not yet been completed.

• 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: 4154445
• MDR Text Key: 4766412
• Report Number: 1644487-2014-02589
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 302-20
• Device Lot Number: 2567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2010
• 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: 38 YR