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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 01/01/2007
Event Type  Injury  
Event Description

It was reported that the vns pt had surgery a "few years back" where the pulse generator was moved from the left to the right chest, due to a burning sensation at the generator site. The pt's current treating physician was not seeing the pt at the time the event occurred, and is attempting to retrieve additional info from the pt, such as the pt's physician at that time, so that attempts for additional info can be made with the appropriate medical professional. In addition, the physician has indicated that the pt is a poor historian and that it is very difficult to get clear description of historical events.

 
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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 Key1552700
Report Number1644487-2009-02717
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/04/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2006
Device MODEL Number102
Device LOT Number10388
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/04/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2004
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: 12/04/2009 Patient Sequence Number: 1
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