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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 08/01/2008
Event Type  Malfunction  
Event Description

Reporter indicated a vns patient had developed two masses in her left breast that were adjacent to the vns generator. It was later reported that the patient was experiencing increased seizures and that a "lead disconnect" was noted on a ct scan. The reporter also stated the vns had migrated to the left axilla, but it is not known if it is the generator or the lead that has migrated. The patient's medications were changed and the vns settings were adjusted as interventions for the seizure increase. The reporter has referred the patient for revision surgery and a surgery date is planned for 2008. Attempts for additional info are in progress.

 
Manufacturer Narrative

Device failure is suspected.

 
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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 Key1191486
Report Number1644487-2008-02363
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/27/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2005
Device MODEL Number302-20
Device LOT Number8280
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/27/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2003
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: 09/26/2008 Patient Sequence Number: 1
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