MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 10/20/2006

Event Type  Injury  

Event Description

It was reported that a patient began experiencing intermittent voice alteration without stimulation.Follow up with the physician revealed he felt vns therapy was most likely the cause; however, he responded the patient's voice change may also be affected by medications or post-nasal drip.Additionally, there were no recent parameter changes that could have caused or contributed to the voice alteration and systems diagnostics were within normal limits.The physician stated the intermittent hoarseness is not associated with stimulation.Follow-up was received from the patient on 11/21/2017 indicting that her vocal cords no longer work because the implanting surgeon got too close to her left vocal cord and it no longer works;.Additional relevant information has not been received 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: 7128822
• MDR Text Key: 95218528
• Report Number: 1644487-2017-05022
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-30
• Device Lot Number: 1316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2005
• 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: 72 YR