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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
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.

 
Manufacturer Narrative

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 Key4102898
Report Number1644487-2014-02400
Device Sequence Number1
Product CodeMUZ
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 Received09/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2002
Device MODEL Number300-20
Device LOT Number737
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/19/2014 Patient Sequence Number: 1
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