MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304; GENERATOR

Model Number 304-20

Device Problem Output Problem (3005)

Patient Problems Pain (1994); Seizures (2063)

Event Date 07/01/2016

Event Type  Injury  

Event Description

Clinic notes were received for patient's generator replacement referral.Notes indicate that the patient needs a new device due to patient's increased seizures.Per mother, patient is having an increase in grand mal seizures since previous clinic visit.Patient is also having pain in the neck from the device.Per notes, the normal mode output current is programmed to 0.0 ma.It is unknown if the increased seizures is due to device programmed off.Additional relevant information has not been received to date.No known surgical interventions have occurred to date.

Event Description

X-ray images with ap views of the neck and chest and lateral views of the neck were received and reviewed.The generator was placed normally per labeling.The connector pin of the lead was visualized past the connector block.The feedthru wires appeared to be intact.The lead electrodes appeared to be appropriately placed per labeling.There were no apparent sharp angles or gross fractures of the lead that could be seen in the provided images.Based on the x-rays received, the cause for the patient¿s pain could not be determined.There was no visual indication of damage to the generator or lead.Patient underwent surgery on (b)(6) 2016.The patient's device diagnostics were all checked prior to surgery and they were within normal limits.Upon removing the generator, the physician saw fluid in the lead tubing and elected to perform a full revision of the lead and generator.The explanted devices have not been received to date.

Event Description

Additional information was received that the patient had been having painful stimulation at the electrode site since the summer and the device was recently turned off by the neurologist.On (b)(6) 2016, two system diagnostics were performed after the patient was intubated (one with patient lying on back and head looking up and another with head turned to right with neck extended) and both diagnostics resulted in normal results (3312 ohms and 3493 ohms (ifi=no)).However when the surgeon took out generator, he stated that he could see fluid in the lead and so decided to replace the leads and generator prophylactically.It was reported that all of the leads were explanted except two helices and that the generator and lead will be returned.The explanted devices have not been received to date.

Event Description

The lead and generator were received.Analysis is underway but has not been completed.

Event Description

Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified in the lab.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse 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.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 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.An analysis was performed on the returned lead portions and the reported allegation of ¿fluid leaks¿ was verified.A portion of the lead was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis an abraded opening was observed on the outer silicone tubing near the electrode bifurcation area.The abraded opening 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.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.The condition of the returned lead portions is consistent with conditions 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 304
• Type of Device: GENERATOR
• 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: 6063498
• MDR Text Key: 58653268
• Report Number: 1644487-2016-02501
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 304-20
• Device Lot Number: 202121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2016; 12/16/2016; 01/24/2017; 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2012
• 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: 12 YR