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

Model Number 302-20

Device Problems High impedance (1291); Device Inoperable (1663)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.The patient reported that the device initially work well, but that after a period of time it was no longer effective.The physician reported that the device would be programmed off.The patient was referred for surgery.No surgical intervention has been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Clinic notes were received indicating that the vns patient¿s increase in seizures was due to a fall that occurred in april 2012 which hospitalized the patient.The patient¿s seizures had increased since the fall occurred so the neurologist adjusted the patient¿s medications.The patient¿s device was previously programmed off in 2012 due to lack of efficacy.No known surgical interventions have occurred to date.

Event Description

An implant card was received indicating that the patient underwent generator and lead replacement due to lead fracture.Further follow-up revealed that the generator was replaced prophylactically.The explanting facility retains explanted product and does not return for product analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of 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.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD MODEL 302
• 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: 3782180
• MDR Text Key: 4445557
• Report Number: 1644487-2014-01146
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2005
• Device Model Number: 302-20
• Device Lot Number: 8434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2003
• 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: 56 YR