MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 11/03/2016

Event Type  malfunction  

Event Description

It was reported that high lead impedance was observed on patient¿s vns system.Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.X-ray was taken and sent to the manufacturer for review.It's unable to verify correct location of the generator due to x-rays partly available.The generator is located on the left side, close to the clavicle.The electrode pin is fully inserted and the feed through wires are intact.There is a suspicion of insulation break at 1 cm from the connector booth.No sharp angles are present no other abnormalities observed on the lead body.The electrodes seem to be aligned with the vagus nerve.No arguments for lead dislocation.Strain relief is present and placed according to the labeling.Two tie-downs are present, but not placed according labeling.Strain relief loop is not present.Based on the images, the cause of the high impedance could not be confirmed, but there is a suspicious area close to the generator.No patient adverse events were reported.No know surgical interventions were performed 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: 6131250
• MDR Text Key: 61294368
• Report Number: 1644487-2016-02745
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 302-20
• Device Lot Number: 202395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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: 20 YR