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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 01/01/2006
Event Type  Injury  
Event Description

Reporter indicated that the pt had their device removed due to pain in the chest and neck that was believed to be caused by the device. All attempts for further info have been unsuccessful to date. Due to procedures at the hospital where the pt had the device removed, the device will not be returned for analysis.

 
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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 Key1478063
Report Number1644487-2009-02049
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2007
Device MODEL Number102
Device LOT Number013834
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/20/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2005
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: 09/18/2009 Patient Sequence Number: 1
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