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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 08/01/2009
Event Type  Malfunction  
Event Description

It was initially reported by the nurse that pt no longer has hoarseness with stimulation and is having increased depression. Diagnostics results showed high lead impedance. Increased depression was back to the pre-vns level. No pt manipulation or trauma was reported. Last good diagnostics were obtained in 2007. No x-rays have been taken or planned. Pt's device has been turned off and is referred to a surgeon for a possible revision surgery.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1506027
Report Number1644487-2009-02074
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/31/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2009
Device MODEL Number302-20
Device LOT Number200228
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/31/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2006
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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