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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 09/01/2011
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported via clinic notes received by the manufacturer that following the generator replacement several years prior, the patient experienced significant side effects and significant pain in his neck. A fractured wire was found and ¿after repair,¿ the patient had experienced improvement in his discomfort. The implant card from the surgery indicated that the impedance at the time of the surgery completion was "ok. " no impedance value was provided. The reason for the vns generator replacement was battery depletion. It was unclear if the lead was repaired using non-manufacturer products or if the lead was replaced. 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8245610
Report Number1644487-2019-00067
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2005
Device MODEL Number302-20
Device LOT Number9405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/22/2003
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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