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

Model Number 302-20

Device Problem Break (1069)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330)

Event Date 03/21/2015

Event Type  malfunction  

Event Description

Initially, it was reported that the patient was experienced spasms and pain at the generator site with device stimulation on time.It was reported that device diagnostics were within normal limits (dc dc code - 2).It was reported that the pain and discomfort had been present for a few days.Device settings were adjusted.It was later reported that the patient and discomfort were not any better with a decrease in device settings and frequency, so the patient was referred for surgery.The device was programmed off pending the surgery.There were no changes in medications or trauma or falls that may have caused or contributed to the pain and discomfort.The patient underwent surgery for patient comfort.The surgeon identified a break in the outer lead tubing in two places therefore, the patient underwent generator and lead replacement.Device diagnostics with the new vns system were within normal limits.The lead and generator were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis was completed for the generator on 04/23/2015.The generator performed according to functional specifications, and there were no performance or any other type of adverse conditions found with the generator.Analysis was completed for the returned lead portion on 04/28/2015.The electrodes were not returned for analysis and therefore, a complete evaluation could not be performed on the entire lead product.Abraded openings were found on the outer and inner silicone tubes.The dried remnants of what appeared to have once been body fluids were found inside the outer and inner silicone tubes.With the exception of the observed abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies, beyond the outer and inner tubing openings, 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, with no discontinuities identified.

Manufacturer Narrative

Evaluation : device failure occurred, but did not cause or contribute to a death.

• 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: 4713766
• MDR Text Key: 5651373
• Report Number: 1644487-2015-04514
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2006
• 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: 25 YR