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

Model Number 302-20

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663); Low impedance (2285)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014.Pre-operative diagnostic results showed lead impedance within normal limits (dc dc ¿ 1).During the procedure, the surgeon noted that the lead¿s silicone coating began to detach from the lead when the lead pin was disconnected from the generator header.The patient¿s new generator and existing lead were tested and diagnostic results showed low lead impedance.The surgeon was eventually able to obtain diagnostic results indicating lead impedance within normal limits and the surgery was completed.During an office visit with his neurologist on (b)(6) 2014, the patient¿s device was tested and diagnostic results revealed low impedance (impedance value < 600 ohms).The patient stated that she did not feel any stimulation.The neurologist elected to keep the patient¿s device programmed on.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.The patient underwent lead replacement surgery on (b)(6) 2014 due to low impedance.The explanting facility will not return the explanted device to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description

An implant card was received confirming that the lead impedance was "ok" at the conclusion of lead replacement surgery on (b)(6) 2014.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Lot#; corrected data: the initial mdr provided the wrong lot # for the suspect device.Device manufacture date; corrected data: the initial mdr provided the wrong manufacture date for the suspect device.

• 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: 3768468
• MDR Text Key: 4373073
• Report Number: 1644487-2014-01096
• 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
• Report Date: 04/01/2014

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: 07/31/2004
• Device Model Number: 302-20
• Device Lot Number: 6593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 04/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/30/2014; 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2002
• 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: 51 YR