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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/01/2009
Event Type  Malfunction  
Event Description

A vns pt's wife called and reported that her husband is implanted with the vns for depression. She called mfr for mri precautions. She reported that her husband had a seizure in (b)(6) of this year. He also lost (b)(6) pounds in the last 8 months and recently has had more seizures. Additionally reported that he is also experiencing left foot drop and left leg paralysis and that is why they need to do an mri. Good faith attempts are being made to determine if the reported events are related to their vns.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1577003
Report Number1644487-2009-02830
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 12/02/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102
Device LOT Number016174
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/02/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2006
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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