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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 08/21/2014
Event Type  Injury  
Event Description

It was reported that the patient began having black out spells and dizziness. A nuclear stress test was performed and was within normal limits. An echocardiogram was done which showed his ejection fraction has decreased and then the patient was placed on a holter monitoring device to record heart activity with the events. The patient will be monitored for a month. The dizziness and blackout spell were happening everyday several times per day and was not associated with a time or day nor with any body positioning (standing or rising, or sitting). The cardiologist of the patient believes it is related to vns and he turned the stimulation down. It was believed that this helped with the events but the patient was still experiencing symptoms.

 
Event Description

Additional information was received when the physician reported that no causal or contributory programming or medication changes precede the onset of the syncope and dizziness. The patient was seen by a cardiologist and diagnosed with neurocardiogenic syncope. The physician stated that there is no relationship between the patient¿s vns and the syncope and dizziness.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4210094
Report Number1644487-2014-02871
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number102
Device LOT Number2344
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/04/2009
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: 10/29/2014 Patient Sequence Number: 1
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