MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Detachment Of Device Component (1104); High impedance (1291)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

It was reported that prior to prophylactic generator replacement surgery, the vns patient¿s device showed high lead impedance.High impedance was not previously observed so no x-rays were taken and the device was not programmed off.The patient¿s generator and lead were replaced during the procedure.The surgeon noted that the electrodes were detached from the nerve.When replacing the generator, the surgeon was able to explant the generator and lead prior to opening the neck incision site.The explanted lead was fully intact and no other issues were noted.No patient manipulation or trauma was reported.The explanting facility discarded the explanted products; 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
• 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: 3802074
• MDR Text Key: 17163446
• Report Number: 1644487-2014-01226
• 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
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 302-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR