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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 01/01/2011
Event Type  Injury  
Event Description

An anonymous vns patient reported that she had lost her voice for the past four years and was having worsening seizures and uncontrollable pain. The relationship of the patient¿s events to vns is unknown.

 
Manufacturer Narrative

Date of this report; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. This report is being submitted to correct this date. Date received by manufacturer; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. The reported date should have been 02/25/2015.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4623367
Report Number1644487-2015-04200
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 02/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2015
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? No
Event Location Other
Date Manufacturer Received03/24/2015
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: 03/23/2015 Patient Sequence Number: 1
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