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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fluid Leak
Event Date 09/22/2017
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for vns generator replacement surgery due to an intensified follow-up indicator, or ifi, condition. During the replacement surgery, it was found that the lead was in a knotted state wrapped around the lead connector pin. It was also reported that the insulation was opened was compromised. Images of the lead condition were reviewed by the manufacturer. There appeared to be an opening in the lead insulation and fluid in the lead. The patient underwent a full vns replacement surgery as a result. Follow up with the company representative revealed that the patient was not a known twiddler and that there was no known trauma or patient manipulation that could have contributed to the condition of the lead. It was reported that the vns was still secured via suture when the patient underwent surgery. The explanted generator and lead have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6957201
Report Number1644487-2017-04634
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number302-20
Device LOT Number1732
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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