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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE NONE

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CYBERONICS, INC. PROGRAMMING SOFTWARE NONE Back to Search Results
Model Number 250
Event Date 06/17/2009
Event Type  Malfunction  
Event Description

It was initially reported that during an appointment, the mother inquired about the pt's magnetic activations. When the nurse practitioner tried to bring up the magnetic history on the handheld computer, no info came up. The nurse then said that they tried swiping the magnet but still nothing came up on the screen under magnet history. During troubleshooting with the mfr, it was discovered that the handheld computer's date was set to 2002. The date was changed at that time to the correct year. When the nurse tried to review the pt's magnet history by searching with the pt's generator serial number, it showed two different pt's initials. The nurse was unable to find the pt's info in the handheld computer. Good faith attempts to obtain additional info have been unsuccessful to date.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1483294
Report Number1644487-2009-01548
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/22/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/22/2009
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

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