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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/07/2013
Event Type  Malfunction  
Event Description

On (b)(4) 2013 it was reported that the patient has seemed depressed, agitated, and has a decreased appetite recently. No device issues are suspected. The patient's device was adjusted from 1. 75 ma back to 1. 5 ma output as the 1. 75 ma was too strong with a pulse width of 500 usec. Diagnostics tests were fine. The patient could not tolerate the higher settings and has been under more stress lately. The physician believes that vns has helped the patient and there was no medication changes. The only further information the physician provided was that the patient is doing well when they decreased the amplitude and on time; there is "no complaint now". No additional information was provided.

 
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Brand NamePULSE GEN MODEL 103
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 Key2989153
Report Number1644487-2013-00587
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/07/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number103
Device LOT Number3366
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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