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

Model Number 300-20

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/25/2015

Event Type  Injury  

Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to jaw pain which occurred during magnet mode stimulation on-times.Clinic notes were received indicating that the patient¿s magnet mode output current was increased from 1ma to 1.5ma during an office visit on (b)(6) 2015.The physician also attempted to increase the normal mode output current of the device from 1ma to 1.25ma but was unable to keep this setting due to patient tolerability issues.Attempts for additional relevant information have been unsuccessful to date.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Analyses of the returned generator and lead have been completed.Analysis concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.The positive coil was found to be protruding out (still within the outer tubing) from the inner silicone tubing at what appear to be abraded/tear openings.Also, an abraded opening was noted on the inner tubing of the negative coil.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative

Evaluation codes: device failure occurred, but did not result in a death.

• 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: 4704217
• MDR Text Key: 5724038
• Report Number: 1644487-2015-04498
• 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: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2002
• Device Model Number: 300-20
• Device Lot Number: 38902C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2000
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR