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

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 03/20/2015

Event Type  malfunction  

Event Description

The patient underwent a full replacement on (b)(6) 2015.The generator was removed from the pocket.The pins were loosened and cleaned as well as the receptacles.Diagnostics performed again and showed a high impedance of 8476 ohms.The explanted generator and lead were received for analysis on (b)(4) 2015.Product analysis is underway but has not been completed to date.

Event Description

It was reported that the patient¿s vns was checked that day and a high impedance warning message was seen.The device was turned off and he was scheduled for chest and neck x-rays.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Product analysis for the generator was completed and approved on (b)(4) 2015.Results from analysis showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the generator's decoder spreadsheet showed that the impedance level changed from 2691 ohms to 8248 ohms on (b)(6) 2015.Product analysis for the explanted lead was completed and approved on (b)(4) 2015.Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The outer and inner tubing abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the abraded inner tubing, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.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.

• 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: 4737858
• MDR Text Key: 5808715
• Report Number: 1644487-2015-04584
• 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,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2001
• Device Model Number: 300-20
• Device Lot Number: 32327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/1999
• 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: 37 YR