MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that the patient had recently undergone generator replacement and that device diagnostics prior to generator replacement were within normal limits.X-rays were taken and reportedly did not identify any discontinuities with the vns system.It was reported that the x-rays would not be sent to manufacturer for review.The patient was referred for surgery.The patient underwent surgery on (b)(6) 2015.The lead pin was removed and then reinserted into the generator header.Device diagnostics again resulted in high impedance.The surgeon then replaced the generator and lead.There were no reported visual abnormalities.There was no trauma or falls that may have contributed to the high impedance.The explanted generator and lead were discarded per hospital policy.

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: 4496046
• MDR Text Key: 20147105
• Report Number: 1644487-2015-03792
• 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
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2000
• Device Model Number: 300-20
• Device Lot Number: 14908C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/1998
• 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: 27 YR