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

Model Number 300-20

Device Problem Defective Device (2588)

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

Event Date 02/27/2015

Event Type  malfunction  

Event Description

During a generator replacement on (b)(6) 2015 due to battery depletion, the surgeon identified the lead insulation on the electrode to be somewhat discontinuous within the generator pocket.Multiple areas of the electrode lead insulation were discontinuous with exposed wire.The surgeon therefore decided to replace the lead along with the generator.The explanted generator and lead were received by manufacturer on 3/12/2015.Analysis is underway but has not been completed.

Event Description

The pulse generator diagnostics were as expected for the programmed parameters.The battery shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.The lead assembly was returned in four portions with one tie down attached.The electrodes were not returned.Multiple abraded opening were observed on the outer silicone tubing and on the marked and unmarked inner silicone tubing.The outer silicone tubing appeared to be compressed in some areas.

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.

• 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: 4635950
• MDR Text Key: 5616849
• Report Number: 1644487-2015-04246
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2002
• Device Model Number: 300-20
• Device Lot Number: 35713C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2000
• 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: 20 YR