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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures, Grand-Mal (2168); Therapeutic Response, Decreased (2271)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

It was reported that the vns patient¿s device showed high impedance during an office visit on (b)(6) 2014.The patient¿s device was not disabled.X-rays were ordered and the patient was referred for surgery.No known surgical interventions have occurred to date.Clinic notes were received for the patient¿s office visit on (b)(6) 2014.The notes indicate that the patient had approximately 1-2 seizures per month since her last office visit three months ago which she described as ¿light.¿ the patient reported recently having a grand mal seizure and going to the er.The neurologist increased the patient¿s medication during the office visit due to the recent seizure.The patient denied any changes in vision and noted that stress and excessive heat can trigger seizures.Further follow-up revealed that the vns patient had a history of grand mal seizures prior to vns.The physician attributed the patient¿s recent seizure to the reported high impedance and subsequent loss of therapy.X-rays were taken and were reported by the physician to be unremarkable.The patient¿s last good diagnostic results were from (b)(6) 2014.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.It may have contributed to the change in seizure pattern.

Event Description

Analysis of the generator and lead was completed.In the 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.The pulse generator diagnostics were as expected for the programmed parameters.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.Note that a large portion 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, three broken coil strands were observed on the (-) connector pin quadfilar coil approximately 120mm-122mm from the end of the connector boot.Scanning electron microscopy was performed identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface.During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 119mm and 131mm from the end of the connector boot.Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 119mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting.Flat spots and pitting were observed on the coil surface.Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 131mm) and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Note that a break of a few strands would still allow current flow through that portion of the lead.This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section.Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• 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: 3885867
• MDR Text Key: 4644458
• Report Number: 1644487-2014-01550
• 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,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2005
• 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): Required Intervention
• Patient Age: 36 YR