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 05/19/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results showed high impedance (dc dc ¿ 7).The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received stating that the vns patient¿s device was not disabled following the high impedance observation.No patient trauma was reported.X-rays were taken but information regarding the images in relation to vns was not provided.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.The generator performed according to functional specifications.A partial lead discontinuity was identified in the positive coil.Scanning electron microscopy images of the positive coil verified that the coil was exposed to some type of electro-cautery tool as indicated by the appearance of the coil wires resulting in a discontinuity of at least three strands at one location.Note that since portion of the lead electrodes were note returned 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

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 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: 3903237
• MDR Text Key: 4677608
• Report Number: 1644487-2014-01638
• 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,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2004
• Device Model Number: 300-20
• Device Lot Number: 5423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2002
• 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: 42 YR