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

Model Number 302-20

Device Problems High impedance (1291); Image Display Error/Artifact (1304)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

Additional information was received that the patient's generator was not disabled following the high impedance observation, as there were no reported side effects or pain associated with the high impedance tests.It was confirmed that high impedance was not seen during generator implant.Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution.No known surgical interventions have occurred to date.

Event Description

It was reported that the vns patient¿s device was tested and both normal mode and system diagnostic results revealed high impedance.Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.Lead impedance was within normal limits at the patient¿s last generator replacement on (b)(6) 2014; the lead pin was completely inserted into the generator header and the lead was not damaged during the procedure.X-rays were provided to the manufacturer for review.The generator appears in the left chest in a normal placement.The filter feed-through wires, lead pin insertion, and lead continuity could not be assessed due to the low resolution of the images provided.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, assessment of the lead could not be performed due to the low resolution of the images provided.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 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: 4664460
• MDR Text Key: 5778480
• Report Number: 1644487-2015-04385
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: 302-20
• Device Lot Number: 201419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2010
• 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: 23 YR