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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 03/19/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was able to tolerate an output current programmed to 1. 25ma but began experiencing adverse effects when the output current was programmed to 1. 5ma. Since this programming change, the patient was experiencing anorexia, decreased appetite, constipation and urinary retention. The physician decreased the output current to 1ma; however, this did not resolve the patient¿s issues. The patient¿s device was programmed off. The patient¿s issues resolved when her device was programmed off. Attempts for additional relevant information were made but have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key3750550
Report Number1644487-2014-00996
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2014
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? Yes
Event Location Other
Date Manufacturer Received03/19/2014
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: 04/15/2014 Patient Sequence Number: 1
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