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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 11/13/2012
Event Type  Injury  
Event Description

On (b)(4) 2013 clinic notes were received dated (b)(6) 2012 which indicated that the patient has a history of open heart surgery. No further information was provided as to why the patient had open heart surgery and the relationship to vns. During this clinical visit the patient denied any chest pain, chest tightness, or chest pressure. The clinic notes indicate that the vns output was set at 2. 5 ma and the magnet output was set to 2. 75 ma. Good faith attempts for further information from the physician have been unsuccessful.

 
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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 Key3167280
Report Number1644487-2013-01768
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2006
Device MODEL Number102
Device LOT Number010275
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/21/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2004
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: 06/13/2013 Patient Sequence Number: 1
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