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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 06/21/2011
Event Type  Injury  
Event Description

It was reported in clinic notes received on (b)(4) 2012 and dated (b)(4) 2011, where it was stated that the patient had cad (coronary artery disease). Additional clinic notes were received on (b)(4) 2012 and dated (b)(4) 2011 where it was stated that the patient had cad, cva (cerebral vascular accident - stroke) and cardiomyopathy. The generator was programmed to 2/30/130/60/3/2/250/60 and the patient was to follow up in six months. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Additional information was received on (b)(6) 2012 when the physician reported that the patient did not have a history of stroke or cardiomyopathy prior to being implanted with vns however he did not indicate a relationship between these events and the patient's vns device. Diagnostic results were provided which indicated normal device function however the date the diagnostics were performed was not provided.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2515621
Report Number1644487-2012-00898
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/06/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number13620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/24/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2005
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: 04/03/2012 Patient Sequence Number: 1
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