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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Insufficient Information
Event Date 02/01/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported by the patient that approximately 9 months ago they woke up and saw that they had developed a blister on their collarbone and could visually see the "copper wrapped vagus nerve directly below it. " by "copper wrapped vagus nerve", it was presumed that meant the lead product. The patient reported that, since this event, he had too many seizures. The patient indicated that the wire (presumably at the point of the blister) appeared visibly smaller than the rest of the wires. The patient reported that the electricity seemed to have problems going through the narrower passage and that the electricity did not reach its intended destination. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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 Key8095658
Report Number1644487-2018-02134
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/23/2018
Device MODEL Number304-20
Device LOT Number203187
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/01/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/09/2014
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: 11/21/2018 Patient Sequence Number: 1
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