MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 10/10/2018

Event Type  malfunction  

Event Description

It was reported during replacement surgery that the lead had a crack and fluid inside of it.The surgeon saw a crack on the casing of the lead.After the lead site was irrigated, the surgeon observed fluid in the lead.It is unclear if the fluid is the irrigation fluid or patient's body fluid.The diagnostics run during replacement indicated that the device was functioning as intended.The lead was not revised due to the normal diagnostics.A representative had attended the appointment prior to replacement and observed normal diagnostics at that time.No additional or relevant information has been received to date.No known lead revision surgery has occurred to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8031252
• MDR Text Key: 125915952
• Report Number: 1644487-2018-01965
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• 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
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 13 YR
• Event Location: Other
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2005
• 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: 50 YR