MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Device Maintenance Issue (1379)

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

Event Date 02/05/2014

Event Type  malfunction  

Event Description

An implant card was received by the manufacturer indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014.The reason for the replacement surgery was due to end of service and high impedance.Additional information was received stating that high impedance was initially observed during the replacement procedure on (b)(6) 2014, it is unknown if patient manipulation or trauma caused or contributed to the high impedance.The explanting facility discarded the device so an analysis cannot be performed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records for 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
• 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: 3677855
• MDR Text Key: 4254633
• Report Number: 1644487-2014-00680
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2014

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: 08/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2008
• 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: 53 YR