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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/18/2013
Event Type  Injury  
Event Description

It was initially reported that a patient had and ekg done which demonstrated concerns for atrial fibrillation. There was no relationship to vns provided. Good faith attempts for additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3156370
Report Number1644487-2013-01716
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/10/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2004
Device MODEL Number102
Device LOT Number7519
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/10/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/16/2002
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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