MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Leak/Splash (1354); Battery Problem (2885)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead.The patient¿s device was explanted because the patient became seizure-free after having resective brain surgery.The explanted generator and lead were returned to the manufacturer for analysis.During visual analysis of the returned lead portion, abraded openings were found on the outer and inner silicone tubes which 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 abraded tubing openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.The setscrew marks found on the lead connector pins 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 the visual analysis, with no discontinuities identified.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Analysis of the returned generator found that the elective replacement indicator was set to ¿yes¿.An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was partially depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion.With the exception of the eri parameter (eri flag was set to ¿yes¿ due to a low battery condition), the device performed according to functional specifications.Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative

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

Event Description

Attempts for additional relevant information have been unsuccessful to date.The patient¿s physician will not provide any additional information as the patient is now seizure free.Review of the available programming and diagnostic history showed that the patient¿s device was disabled on (b)(6) 2007.At the patient¿s next office visit on (b)(6) 2013, the patient¿s device was still disabled.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 3923831
• MDR Text Key: 21171134
• Report Number: 1644487-2014-01745
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2004
• Device Model Number: 300-20
• Device Lot Number: 5213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2002
• 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: 29 YR