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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2002
Event Type  Injury  
Event Description

Clinic notes were received indicating that a patient had experienced recurrent laryngeal nerve injury with vns. Per the notes, the patient also experienced a cough with mild pharyngeal pain or dysphagia. Programming history was reviewed for the patient's device, and diagnostics were within the normal limits on the date of implant and one month after implant surgery. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

The physician reported that the patient experienced paresis in the recurrent laryngeal nerve due to initial vns implant surgery, which occurred nearly 14 years prior to the clinic notes. No medical intervention was taken for the nerve injury as it was a one time surgical injury. No additional relevant information has been received to date.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 Key7335848
Report Number1644487-2018-00368
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2003
Device MODEL Number300-20
Device LOT Number2802
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/05/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/18/2001
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: 03/13/2018 Patient Sequence Number: 1
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