MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692); Fibrosis (3167); No Code Available (3191)

Event Date 03/08/2017

Event Type  malfunction  

Event Description

It was reported that a patient was having lead problems related to her clotting disorder.The patient believed that her physician told her that this was the case and stated that she needed to undergo full revision surgery to resolve the issue.No further relevant information has been provided to date.No surgical intervention has occurred to date.

Event Description

The patient underwent generator replacement surgery.The lead was not replaced as the surgeon reportedly did not feel it necessary to replace the lead.No additional relevant information has been provided to date.

Event Description

It was reported that the patient was actually experiencing a tethering sensation accompanied by pain and discomfort when she turned her head.The lead was only repositioned during generator replacement surgery.The lead repositioning was for patient comfort.The surgeon believed that scar tissue formation, and not a clotting disorder, was the cause of the patient's lead issues.No additional relevant information has been provided to date.

• Brand Name: LEAD MODEL 304
• 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: 6449279
• MDR Text Key: 71382418
• Report Number: 1644487-2017-03525
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• 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 Outcome(s): Other
• Patient Age: 45 YR