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

Model Number 304-20

Device Problem Low impedance (2285)

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

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a vns patient's device showed low impedance at 600 ohms.No injuries, falls, or trauma were reported.It was stated by the patient's mother that they get efficacy from the magnet.The patient has been referred for full revision.Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective.An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation." the device had been programmed off on (b)(6) 2016.Lead and generator revision surgery occurred on (b)(6) 2016.A lead break was visualized approximately one-third of the distance from the generator.The explanted devices have not been received to-date.Additional relevant information has not been received to-date.

Manufacturer Narrative

Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.

Event Description

The explanted devices were received for analysis on 10/05/2016.Analysis was performed on the returned lead portion 10/24/2016.The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes.The coils were bare and exposed in the areas of the abraded openings.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.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium.With the exception of the twisted appearance and 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 portion were performed, during the visual analysis, and no discontinuities were identified.Analysis was completed for the returned generator 10/27/2016.The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016.The device was explanted later on (b)(6) 2016.Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.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 output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 3.055 volts and shows an intensified follow-up indicator was not set.18.519% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the downloaded generator data revealed no anomalies.

• Brand Name: LEAD MODEL 304
• 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: 5916022
• MDR Text Key: 54266614
• Report Number: 1644487-2016-01958
• 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: Initial,Followup,Followup
• Report Date: 08/01/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/30/2016; 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• 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: 9 YR