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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 11/01/2011
Event Type  Injury  
Event Description

It was reported that a patient was hospitalized due to issues with asthma on (b)(6) 2011 and previously, in (b)(6) 2011. Per the patient, the device had previously been programmed off but when it was programmed back on, the patient began to have issues with asthma. Follow up with the patient's treating physician revealed that the device stimulation is probably a contributing the asthma as it appears to come and go with the device on and off; however, when on, the asthma is not limited to stimulation on times only. The patient does have a medical history of asthma prior to being implanted with vns. There were no causal or contributory medication or programming changes prior to the onset of the asthma. The device was programmed off on (b)(6) 2011 per the physician when the patient was in the emergency room due to asthma. No additional information was provided.

 
Manufacturer Narrative

 
Manufacturer Narrative

Date received by manufacturer (mm/dd/yyyy), corrected data: initial report selected (b)(6) 2011 as the aware date; however the aware date is (b)(6) 2011.

 
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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 Key2379152
Report Number1644487-2011-03130
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number102
Device LOT Number11863
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/19/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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: 12/16/2011 Patient Sequence Number: 1
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