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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number 250
Event Date 05/03/2010
Event Type  Malfunction  
Event Description

It was reported that a patient was seen in clinic and their vns was interrogated and showed 0. 25ma/10 hz. It was intended for the patient to be programmed to 1. 5ma/30/500/30/3 min off time. The patient event was discovered on (b)(6)2010. It is unk if another programming system was used to program the patient to these settings as not default settings. The patient was programmed back to their intended therapy. Around the time of their programming event, the patient was having an increase in seizures from weekly to daily when they were at unintended therapy. Their seizures had changed and involved left side stiffening and head turning to the left that lasted 30 seconds. Overall, in the past several months, it has been reported that their seizures have been slightly more frequent. Good faith attempts are underway.

 
Manufacturer Narrative

Analysis of programming history confirmed reported settings.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1774009
Report Number1644487-2010-01673
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 07/21/2010 Patient Sequence Number: 1
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