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

Model Number 302-30

Device Problem Low impedance (2285)

Patient Problem Seizures (2063)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2015 a physician asked whether low impedance in diagnostic testing (60;600) is suggestive of a short circuit.The physician later reported that he does have a patient with low impedance.This low impedance was first observed on (b)(6) 2015 on a system diagnostics test.The physician did not make any changes to the patient's settings at that time.The physician indicated that the patient has an intellectual disability and therefore is unable to express any change in stimulation perception, but that the patient's seizures have been increasing since her last visit in (b)(6).Although surgery is likely, it has not occurred to date.

Event Description

On (b)(6) 2015 the patient's generator product information was provided by the implanting facility.

Event Description

It was reported that the patient is having an evoked potential test.

Event Description

On (b)(4) 2015 it was reported that the patient underwent a full revision surgery that day.Attempts were made for the return of the explanted products but they have not been received to date.

Event Description

On (b)(6) 2015 the explanted generator and lead were received for product analysis.Product analysis has been completed on the generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.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.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; there were no performance or any other type of adverse conditions found with the pulse generator.Product analysis is still underway on the leads and has not yet been completed.

Event Description

Product analysis was completed on the leads on 1/25/2016.The majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis abraded openings were observed on the outer and in one area of the connector ring inner silicone tubing.The quadfilar coil appeared to be stretched and exposed.The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

• 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: 4932439
• MDR Text Key: 22677528
• Report Number: 1644487-2015-05288
• 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: Followup,Followup,Followup,Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2006
• Device Model Number: 302-30
• Device Lot Number: 010850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2004
• 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 Outcome(s): Other
• Patient Age: 20 YR