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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2013

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that the patient underwent generator replacement several months ago due to high impedance, but that the high impedance resolved with generator replacement (mfr.Report # 1644487-2013-01609).The implant card from the generator replacement surgery confirmed that the lead impedance was ok with the new generator and existing lead (3342 ohms and 3589 ohms).Further follow-up revealed that x-rays were taken.Attempts to obtain additional relevant information have been unsuccessful to date.Surgery is likely, but has not occurred to date.

Event Description

The treating physician reported that he does not attribute the patient's worsened seizures to vns.The worsened seizures were described as a possible increase in frequency that was not worse than prior to vns implant.X-rays were unremarkable.

Event Description

It was reported that the patient had generator and lead replacement surgery on (b)(4) 2014.It was reported that after the generator was replaced, high lead impedance still resulted with the existing lead.Therefore, the lead was also replaced.The suspect device was received by the manufacturer for analysis.However, analysis has not been completed to date.

Manufacturer Narrative

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

Event Description

The neurology office reported that the patient was being referred for surgical evaluation due to high impedance.X-rays performed in (b)(6) 2014 did not show any lead break issues per the neurology office.It was reported that the device has not been disabled.Additional information received from the nurse revealed that the high impedance was first observed on (b)(6) 2013.No patient manipulation or trauma is believed to have contributed to the high lead impedance.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient was hospitalized on several occasions recently due to seizures with high lead impedance.X-rays were performed and assessed by the treating vns physicians, and no obvious lead issues were observed.

Manufacturer Narrative

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

Event Description

Analysis of the suspect device and generator was completed.Abraded opening were noted in the outer and the negative inner silicone tubing, and two breaks were identified in the negative coil.Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break locations and on the coil surfaces with dark appearance.Scanning electron microscopy images of the negative coil breaks show appearance suggesting that a stress-induced fracture has occurred in at least two strands at the break located at ~17.9cm from boot.However, due to metal dissolution, surface contamination, and mechanical distortion the fracture mechanism of the other strands and the second coil break located at approximately 18.8cm from boot cannot be ascertained.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions.Note that since the anchor tether silicone helix was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 3897105
• MDR Text Key: 4648131
• Report Number: 1644487-2014-01601
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2004
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR