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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 07/07/2014

Event Type  malfunction  

Manufacturer Narrative

Corrected data: the initial mfr.Report reported the incorrect date.The date should have been 07/15/2014.The change of date does not change that the report was submitted prior to the 30 day deadline.The initial report is not late as a result of the changed date.

Event Description

It was reported that the vns patient was experiencing painful stimulation.The patient¿s device was disabled during an office visit on (b)(6) 2014 and the pain subsided.The patient was referred for surgery and seen on (b)(6) 2014 for a surgical consult.Several positional system diagnostic tests were performed, and all showed lead impedance within normal limits except one.When the patient was standing and leaning over with his head on the exam table, the patient¿s device showed high impedance.The high impedance observation was believed to be due to a microfracture.It was reported that the patient may have manipulated the device.The patient¿s seizures had also increased but not above pre-vns baseline levels.X-rays were taken and were reported by the physician to be unremarkable.The patient was scheduled for surgery on (b)(6) 2014.Several system diagnostic tests were performed before and during the procedure which all showed lead impedance within normal limits (dc dc ¿ 2).Thus, the surgeon elected to cancel the procedure.No known surgical interventions have occurred to date.

Manufacturer Narrative

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

Manufacturer Narrative

Event description, corrected data: the date of the clinic visit where the device was disabled was inadvertently reported in the initial report as (b)(6) 2014, when the visit had occurred on (b)(6) 2015.

Event Description

It was reported that since a lead fracture could not be found at surgery on (b)(6) 2014 the family of the patient decided not to have the lead changed.The device was programmed off to assess whether the patient needed vns before deciding to replace the device.Since the device had been turned off over the year prior, the patient experienced a "major backslide".The patient has been referred again for revision of the lead and generator.No known surgical intervention has occurred to-date.

Manufacturer Narrative

The initial report inadvertently did not report that the patient also experienced coughing in addition to the painful stimulation.

Event Description

It was reported that the vns patient was experiencing painful stimulation and coughing.

Event Description

The generator and lead were replaced on (b)(6) 2015.The reason for replacement was reported as due to a lead discontinuity.The explanted products have not been received to-date.No additional relevant information has been received to-date.

Event Description

The explanted products were received for analysis.Analysis was completed for the returned generator 02/04/2016.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The septum was not cored.The generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis was completed for the returned portion of the lead on 02/16/2016 and the reported event was not verified within the returned lead portion.Note that since 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.

• 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: 4006205
• MDR Text Key: 17497250
• Report Number: 1644487-2014-02007
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/15/2014

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: 11/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/15/2014; 11/04/2015; 12/07/2015; 01/18/2016; 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2006
• 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: 13 YR