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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 04/07/2010
Event Type  Injury  
Event Description

It was initially reported that a pt was experiencing urinary retention as a result of a change in the pt's duty cycle for stimulation. The pt was previously noted to be experiencing larynx constriction caused by the stimulation when she was programmed to higher than 0. 75ma. At this time the pt's duty cycle was adjusted to accommodate for the intolerable higher settings. The pt was known to be experiencing efficacy from the duty cycle with the lower output current. Her physician ran some tests (specifics are not known), and it was observed that when the device was disabled, the pt was able to urinate properly. The physician has changed the stimulation off-time to see if this will resolve the issue and still maintain the seizure control. There is no other known cause for the event. The pt's diagnostic tests are said to be within normal limits, but no specifics were made available. The pt is expected to return to the physician for follow-up on the issue.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1678646
Report Number1644487-2010-01110
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/07/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number103
Device LOT Number2160
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/07/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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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