MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Operates Differently Than Expected (2913)

Patient Problems Asthma (1726); Edema (1820); Paralysis (1997); Respiratory Distress (2045)

Event Date 04/24/2001

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 reported that by the patient¿s report, she had occasions of unilateral vocal cord paralysis following vns procedure.Subsequently, she seemed to stabilized after undergoing a vocal fold injection procedure.The vocal folds were evaluated to be bilaterally mobile with exhibition of mild edema.The patient presented with report of progressively worsening breathing difficulties.The vns generator was programmed off to 0ma which the physician evaluated may provide some immediate relief with respect to the breathing issues.It was previously reported that the patient had vns programming changes made due to tolerability issues including with subtle hoarseness during stimulation but was tolerated.A note from (b)(6) 2007 indicated the patient had increasing breathing problems and was unknown if related to a recent increase in settings.Later in (b)(6) 2008, the patient felt the breathing issues were related to vns and as a result did not want to increased settings.In (b)(6) 2008, the treating physician indicated the patient¿s asthma was worse and unknown if related to vns at that time.The patient's previously treating physician who managed the vns treatment has retired.

Event Description

Operative notes from explant surgery on (b)(6) 2014 were received and indicated that the pre- and post-operative diagnoses was dyspnea and chronic laryngitis.The indication for procedure detailed that the patient developed chronic laryngitis with symptoms of constriction of the larynx after vns implant, which may be related to the vagal nerve stimulator lead.The surgeon noted that they had concerns that the vagal nerve stimulator may be ¿inappropriately activating the recurrent laryngeal nerve.Because of this, the device will need to be removed." the generator (including surrounding scar tissue) and majority of lead were explanted; all of the electrodes were not explanted, ¿recognizing the risk of additional dissection was certainly not warranted by any benefit of harvesting additional nerve lead wire.¿.

Event Description

The patient had generator and lead explant surgery on (b)(6) 2014 to undergo other indication treatment.The explanted products were discarded.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4102898
• MDR Text Key: 4697266
• Report Number: 1644487-2014-02400
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2002
• Device Model Number: 300-20
• Device Lot Number: 737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2000
• 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: 57 YR