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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 10/25/2014

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).It was noted that the patient had been experiencing an increase in seizures.The patient underwent generator and lead replacement surgery on 01/02/2015.The explanted devices have not been returned to date.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received that no patient manipulation or trauma was known to have occurred which may have contributed to the high impedance.The explanted generator and lead were received for analysis.Analysis of the explanted generator showed proper functionality of the pulse generator in its ability to provide appropriate programmed output currents.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the generator's internal data showed that the high impedance occurred sometime on or prior to (b)(6) 2014.Analysis of the explanted lead was completed and confirmed discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions.Abraded openings of both the outer and inner tubing were observed as well, which provided paths for the observed fluid leaks.Furthermore, pitting was observed near the break locations.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• 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: 4430468
• MDR Text Key: 5419580
• Report Number: 1644487-2015-03653
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2010
• Device Model Number: 302-20
• Device Lot Number: 1925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2007
• 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: 17 YR