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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Complaint, Ill-Defined (2331)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (5,000 ohms).It was reported that device diagnostics were within normal limits at the patient's previous visit in (b)(6) 2014.It was later reported that the device was programmed off and the patient was referred for x-rays.The patient's mother reported that the patient complained of feeling something moving in his neck approximately one month prior following a seizures.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical interventions have been performed to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received that the patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator placement and high impedance.Pre-operative diagnostics showed normal impedance, although it was confirmed that diagnostics during the prior office visit showed high impedance at 5356 ohms.The surgeon also identified two visible breaks in the lead insulation during the surgery.The generator and lead replacement surgery was completed.Additional information was received that the explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

• 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: 4452647
• MDR Text Key: 5425334
• Report Number: 1644487-2015-03699
• 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
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2005
• 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: 19 YR