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

Model Number 302-20

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Code Available (3191)

Event Date 07/31/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6)2015 due to desire for the latest generator model.During the procedure, the surgeon observed fluid in the lead insulation and twisting of the lead at the generator pocket possibly due to patient manipulation.Diagnostic tests with the replacement generator and existing lead showed lead impedance within normal limits (impedance value - 3205 ohms).The surgeon elected not to replace the lead and untangled the lead before completing surgery.The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned generator determined that the eos condition was the result of normal battery depletion.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

• Brand Name: LEAD MODEL 302
• 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: 5029560
• MDR Text Key: 24933067
• Report Number: 1644487-2015-05617
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/31/2015

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: 02/29/2008
• Device Model Number: 302-20
• Device Lot Number: 945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2005
• 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: 21 YR