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

Model Number 302-20

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Complaint, Ill-Defined (2331)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014.The notes indicate that the patient was concerned about possible lead protrusion.The physician stated that lead impedance was within normal limits.It was reported that the patient went to the er on (b)(6) 2014 due to potential extrusion of the tie-downs.The extrusion was described as ¿blackhead-like things¿ that were extruding from the patient¿s neck.No issues with the device were observed.It was noted that the patient had some itchy spots at her clavicle.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.One set of electrodes appears to have been abandoned.Part of the lead was behind the generator and could not be assessed.There appears to be a sharp angle extending out from the medial portion of the generator.No clear lead breaks were found in the parts of the lead that could be assessed.A tie-down was visualized, securing the strain relief bend and loop.Based on the images provided, the reported extrusion of the tie-downs cannot be assessed or confirmed.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported that the patient scratched the skin over the lead wires, but that there was no extrusion.The physician reported that there was no black spots present on the patient's skin related to vns.The physician believes that the patient scratched the skin due to device stimulation and that the area has been covered to discourage the scratching.The physician is considering decreasing the device stimulation.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, the reported extrusion of the tie-downs cannot be assessed or confirmed.

• 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: 3971748
• MDR Text Key: 4636046
• Report Number: 1644487-2014-01913
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2005
• 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 Outcome(s): Other
• Patient Age: 20 YR