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

Model Number 302-20

Device Problem High Test Results (2457)

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

Event Date 07/05/2013

Event Type  malfunction  

Event Description

During an internal review of programming and diagnostic data, it was found that the vns patient's device was tested on (b)(6) 2013 and system diagnostic results revealed high impedance >=10000 ohms.The device was tested again on (b)(6) 2013 and system diagnostics returned again high impedance with >=10000 ohms.New tests were run on (b)(6) 2013 and system diagnostics returned impedance results within normal limits with 2317 ohms.No patient adverse events were reported.No known surgical interventions were reported to date.

Event Description

Further information was received indicating that the patient underwent a battery replacement on (b)(6) 2013 and intraoperative system diagnostics returned impedance within normal limits.Based on info available, the previously reported high impedance was likely the result on system diagnostics test performed on the generator before the implant of the device.

Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong age for the patient.

• 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: 5007031
• MDR Text Key: 24435901
• Report Number: 1644487-2015-05513
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2007
• 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: 6 YR