MAUDE Adverse Event Report: CYBERONICS BIPOL LEAD MODEL 300

Model Number 300-30

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Paralysis (1997); Weight Changes (2607)

Event Date 07/27/2005

Event Type  Injury  

Event Description

The patient or patient's representative reported on (b)(6) 2005 that the patient's vns implant lead migrated over the larynx, and the left vocal cords were not working.The patient had generator replacement for re-implant with a smaller device and leads were repositioned at that time.The generator replacement due to migration of the device was previously reported in manufacturer report #: 1644487-2005-00735.The surgeon's notes further reported that the device's lead had gradually migrated medially.Another reason for generator replacement was persistant mild trouble swallowing (dysphagia) that occurred intermittently.The persistent dysphagia was possibly related to the medial migration of the lead.Consult notes from the surgeon dated (b)(6) 2001 reported that at that time, the patient had normal vocal fold mobility.Some reflux was noted.The surgeon documented that it was possibly globus symptoms related to reflux.He was not sure how the vagal nerve stimulation would exacerbate some reflux, but nevertheless he indicated that it could be possible.However, notes dated (b)(6) 2005 reported that "on fiberoptic examination today reveals normal moving cords bilaterally whereas just in couple of months she had no movement of the left vocal fold.There may have just been a temporary neurapraxia from the stimulator." a study nurse reported that the patient had began exercising and losing weight and the lead migration and dysphagia occurred as a progression of the patient's improved physical conditioning.The generator replacement and lead repositioning was considered by the surgeon to also be cosmetic.Follow up with the patient's currently treating vns physician in (b)(6) 2014 revealed that he is not aware of the patient ever having vocal cord paralysis.He has never noticed any symptoms from the patient that would suggest vocal cord paralysis.He reports that he does vaguely recall where she has talked about that she does talk lower and slower with the physician.However, she does not have voice alteration.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 3774139
• MDR Text Key: 16804442
• Report Number: 1644487-2014-01114
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2005

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: 10/31/2000
• Device Model Number: 300-30
• Device Lot Number: 16551C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/28/2005
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/1998
• 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): Required Intervention
• Patient Age: 52 YR