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

Model Number 300-20

Device Problem Degraded (1153)

Patient Problem No Code Available (3191)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

Corrected data: the initial report inadvertently did not include additional detail on the fluid leaks in the lead.

Event Description

The lead assembly had dried remnants of what appear to have once been body fluids inside the identified inner and the outer silicone tubing openings.

Event Description

A patient underwent full prophylactic replacement surgery due to the desire for the latest generator model on (b)(6) 2016.The patient's explanted generator and lead were returned to the manufacturer for product analysis.Abraded openings were noted on the outer and the inner silicone tubing of the explanted lead.No other anomalies, other than those mentioned above, were identified in the returned portion of the lead.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.During the product analysis, there were no anomalies found with the pulse generator.

• Brand Name: LEAD MODEL 300
• 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: 5725759
• MDR Text Key: 48414742
• Report Number: 1644487-2016-01299
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

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: 06/30/2003
• Device Model Number: 300-20
• Device Lot Number: 3446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2001
• 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: 60 YR