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

Model Number 302-20

Device Problems Kinked (1339); Moisture or Humidity Problem (2986)

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

Event Date 01/05/2016

Event Type  malfunction  

Event Description

A physician reported that during a generator replacement surgery, he observed that the previously implanted lead appeared to be kinked (bended and folded) where the lead and pin meet.At this location there was a small horizontal slit in the lead and fluid was seen inside the lead body.The surgeon believes that the fluid and slit were due to the observed kink.No high or low impedance or adverse events had been observed with the system prior to the generator replacement surgery; pre-surgical impedance was reported to be 1,875 ohms.The surgeon replaced the generator and connected the new generator to the lead.With the new generator the lead impedance remained within normal limits at 2,255 ohms.Although the system was exhibiting normal lead impedance the physician elected to replace the lead given the observation of compromised insulation and fluid within the lead.Review of available programming and diagnostic history revealed no anomalies and no abnormal lead impedance values.The explanted pulse generator and lead have not been received by the manufacturer to date.

Event Description

The explanted lead and pulse generator were returned to the manufacturer for product analysis.Analysis of the lead showed abraded openings on both the inner and outer silicone tubing.The positive coil was exposed in one of the areas of the abraded openings and showed smoothed surfaces due to wear.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing.No discontinuities were identified within the returned lead portion.There were no performance or any other type of adverse conditions found with the pulse generator.The battery, 2.720 volts as measured during testing, shows an ifi=yes condition.

• 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: 5399459
• MDR Text Key: 37714935
• Report Number: 1644487-2016-00076
• 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: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 302-20
• Device Lot Number: 2351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2009
• 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: 13 YR