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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 12/01/2008
Event Type  Malfunction  
Event Description

It was reported that a vns patient had been using his magnet more often than usual, however, when the physician checked the patient's magnet activation history in his handheld device, the information presented did not match the patient's description. The magnet activations shown on the handheld device for this particular patient's generator did not correlate with the magnet swipes the patient performed. The physician was sent a replacement handheld device and his old handheld was sent back to the manufacturer for analysis. The handheld and software have been received, however, device evaluation has not been completed at this time.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1363945
Report Number1644487-2009-00096
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/18/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521380
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/23/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/18/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2006
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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