MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-30

Device Problem Low impedance (2285)

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

Event Date 07/29/2015

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2015 that a low impedance warning message was seen on a patient's device upon interrogation.This was the patient's first appointment after battery replacement on (b)(6) 2015.It was noted that after the replacement, diagnostics were taken and came back in range.It was then noted that following a running of the system diagnostics the impedance resulted in range, 1692 ohms.The decoder information from generator was received and indicated that the impedance values were fluctuating from normal impedance values back to low impedance values and then back to normal impedance.Based on these impedance values it is clear that there is a short in the circuit causing the impedance to fluctuate between normal and low readings.This is likely due to wear on the lead based on the age of the device.While surgical intervention is likely, no surgery has been planned or scheduled to date.

• Brand Name: LEAD MODEL 303
• 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: 5048038
• MDR Text Key: 25397599
• Report Number: 1644487-2015-05678
• 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: company representative
• Reporter Occupation: Other
• Report Date: 08/11/2015

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: 05/31/2015
• Device Model Number: 303-30
• Device Lot Number: 201776
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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: 13 YR