MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s diagnostic results revealed high lead impedance.The device was subsequently programmed off and x-rays were not planned to be taken.Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014.The notes indicate that the patient has not used her magnet since 2012 and has not appreciated any seizure auras since (b)(6) 2013.The patient believes that the vns device is working normally.The patient was referred for generator and lead replacement surgery.Surgery is likely but has not taken place.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that the patient underwent generator and lead replacement.It was reported that device diagnostics with the new system was within normal limits (1640 ohms).It was reported that the explanting facility does not returned explanted devices without prior patient consent; therefore, the generator and lead will not be returned for analysis.

Event Description

A review of available patient programming history revealed that last known successful diagnostics were received in 2012.

• Brand Name: LEAD MODEL 302
• 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: 3675573
• MDR Text Key: 4240268
• Report Number: 1644487-2014-00668
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2014

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: 06/30/2013
• Device Model Number: 302-20
• Device Lot Number: 201126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2014; 05/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2009
• 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: 24 YR