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 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported the patient was found to have high lead impedance on (b)(6) 2016.The patient denied any trauma which may have caused the device failure.Chest x-rays were ordered and a battery life calculation was performed to see if the patient would need a full vns revision.A battery life calculation was performed which showed the device had approximately 1.4 years remaining until neos = yes (near end of service).The programming history database was reviewed; however, only information from 10/27/2010 through 12/15/2015 was available.No anomalies were noted within the available information.Information was later received confirming that the patient did have high impedance on (b)(6) 2016.

Event Description

An implant card was received showing the patient was re-implanted with a new generator and lead on (b)(6) 2016.The generator and lead were later received by the manufacturer for product analysis.During lead product analysis, a lead break was not confirmed.However, it should be noted that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.What appeared to be specs of white deposits were observed in various locations.Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur, and calcium.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No 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 visual analysis, and no discontinuities were identified.Based on the findings in the pa lab, there was no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance.Product analysis for the returned generator was also completed and found that the generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.

• 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: 5793446
• MDR Text Key: 50409192
• Report Number: 1644487-2016-01585
• 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
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2005
• Device Model Number: 302-20
• Device Lot Number: 8773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2003
• 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 Age: 57 YR