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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 03/31/2009
Event Type  Malfunction  
Event Description

It was reported that a physician's handheld was showing multiple dates. The physician called the manufacturer for further instructions. The physician then performed magnet mode diagnostics and re-interrogated the patient, but the issued prevailed. Further information from the manufacturer to the physician indicated that the patient's generator was fine and that it was related to roll-over of total time and magnet activations which should resolve once the patient has had fifteen magnet activations. The physician acknowledged and the stated that he would re-interrogate the patient's generator at the next visit. Information received by a company representative revealed that the patient was seen by the physician for an eeg and the physician did not re-interrogate the device. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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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 Key1425021
Report Number1644487-2009-00821
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/31/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number537101
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/31/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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