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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 Fracture
Event Date 02/13/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient underwent a full generator and lead revision due to a possible lead fracture. Follow-up with the patient's physician found that high impedance had been detected at the patient's last appointment. A month prior to the appointment, the patient reportedly had an increase in seizures, a change in seizure profile, and was cyanotic during and after her seizures. The physician attributed these events to loss in therapy due to a lead fracture. The surgeon indicated that he had performed generator diagnostics and visualized a lead fracture during surgery. The suspect product has not been received to date. No further 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 Key6502912
Report Number1644487-2017-03638
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number302-20
Device LOT Number200822
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2008
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: 04/19/2017 Patient Sequence Number: 1
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