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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 11/01/2008
Event Type  Injury  
Event Description

Reporter indicated that the pt will be referred for a generator revision surgery. The pt complained of increased depression. Review of the pt's programming history available in the in-house database revealed that the device is not at end of service, however, this is based off the limited programming and device diagnostic information. The pt has been referred for a surgical consult and good faith attempts to obtain additional information from the pt's treating physician have been unsuccessful to date.

 
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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 Key1444529
Report Number1644487-2009-01739
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/24/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012407
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/24/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
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: 08/17/2009 Patient Sequence Number: 1
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