MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Break (1069); Device Inoperable (1663); Moisture or Humidity Problem (2986); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was scheduled for surgery due to end of service.Pre-operative diagnostic results showed output current = low.During the procedure, the outer silicone tubing of the lead appeared to be ¿stripped¿ and fluid was noted to have entered the outer silicone tubing.The surgeon elected to wrap catheter tubing around the stripped portion of the lead.Only the generator was replaced during the procedure.Post-operative diagnostic results showed output current = ok.The explanted generator has not been returned to date.

Manufacturer Narrative

Device failure is suspected, 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
• 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: 4262831
• MDR Text Key: 5010875
• Report Number: 1644487-2014-03085
• 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
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2003
• Device Model Number: 300-20
• Device Lot Number: 4398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2001
• 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: 51 YR