MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-30

Device Problem Low impedance (2285)

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

Event Date 08/25/2015

Event Type  malfunction  

Event Description

During an implant surgery, the surgeon reported that the electrodes seemed to be "straighter" and that the electrode coils didn't have the normal turns so it was more difficult to wrap around the nerve.Diagnostics performed with this lead were recorded the impedance to be 748 ohms and 800 ohms.Due to the lower impedance value, the surgeon opted to replace the lead.The explanted lead was received on (b)(6) 2015.Analysis is underway but has not been completed to date.An impedance value greater than 600 ohms and less than 5300 ohms is considered to be within normal limits.

Event Description

Analysis was performed on the returned lead portion.The lead was returned intact.During the visual analysis the (+) white and (-) green electrode ribbons appeared to be stretched and the helices misshaped.This most likely occurred due to manipulation of the lead during the attempted implant procedure while attempting to place the electrodes on the vagus nerve.The condition of the lead assembly returned is consistent with conditions that typically exist following an attempted implant procedure; therefore the absence of abrasions on the connector boot and outer silicone tubing is evidence that the lead assembly was not fully implanted.Continuity checks of the returned lead assembly were performed with no discontinuities identified.Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.Based on the findings from product analysis, there is no evidence to suggest an anomaly with the returned device which may have contributed to the stated complaint.A review of device history records for the lead shows that no unresolved non-conformances were found.

• Brand Name: LEAD MODEL 304
• 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: 5085587
• MDR Text Key: 26429000
• Report Number: 1644487-2015-05659
• 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: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-30
• Device Lot Number: 202579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2013
• 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: 54 YR