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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 01/01/2008
Event Type  Injury  
Event Description

During a retrospective study of a multi-center pt record review for pts previously implanted in (b)(6), it was indicated that the pt was noted as having a "new seizure type - partial" at the 1-year f/u. The mfr's programming history database was reviewed, which indicated that the pt's last known diagnostics were within normal limits. Good faith attempts have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key2237082
Report Number1644487-2011-02043
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2009
Device MODEL Number103
Device LOT Number16672
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/02/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2007
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: 09/01/2011 Patient Sequence Number: 1
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