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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 02/27/2013
Event Type  Injury  
Event Description

It was reported that the patient has a defibrillator implanted. It is unknown to date if the defibrillator is related to the vns or if it is a separate event.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key3026370
Report Number1644487-2013-00847
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/28/2013 Patient Sequence Number: 1
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