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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

A patient underwent replacement surgery to resolve high impedance present on her vns device, as reported in mfr. Report # 1644487-2016-01548. The surgery was aborted because the explanting physician accidentally punctured the patient's jugular vein, requiring another physician to repair the patient's vein. Per a company representative, the patient stayed in the icu overnight to recover. No additional relevant information has been received to date.

 
Event Description

The patient's mother reported to a company representative that the patient experienced voice issues, swallowing, coughing, and hoarseness as a result of the injuries sustained during surgery. The patient's family was concerned with the potential for choking while drinking and vocal cord paralysis. The surgeon reported that the patient experienced a lot of swelling but expected the patient's voice to heal. An ent referred the patient for a modified barium swallow test to evaluate the patient's condition. No additional relevant information has been received to date.

 
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Brand NameLEAD 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 Key7275417
Report Number1644487-2018-00226
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 03/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2003
Device MODEL Number300-20
Device LOT Number4105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/17/2001
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: 02/15/2018 Patient Sequence Number: 1
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