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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 MODEL 250
Device Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2015
Event Type  malfunction  
Event Description
An analysis was performed on the returned flashcard and no anomalies associated with the vns software were identified.During the analysis it was identified that the vns software would not load into the handheld.The cause for the identified anomaly is associated with a defective flashcard.No further anomalies were identified.An analysis was performed on the handheld and no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician¿s handheld computer did not install the vns programming software.The medical professional indicated that the handheld computer displayed the operating system¿s screen despite attempting a hard reset.It was reported that the vns software flashcard was properly inserted in its compartment of the handheld computer.The software flashcard and the handheld computer have been returned to the manufacturer.Analysis is underway but it has not been completed to date.
 
Manufacturer Narrative
 
Event Description
An analysis was performed on the returned serial cable and no anomalies associated with the serial cable were noted.The serial cable performed according to functional specifications.
 
Event Description
The flashcard was sent to the manufacturer and the cause for the anomaly is associated with a damaged connector pin.No other anomalies were identified.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4773717
MDR Text Key5941273
Report Number1644487-2015-04688
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 04/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 250
Device Lot Number1063528
Other Device ID NumberVERSION 8.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2015
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 07/14/2015
Initial Date FDA Received05/15/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received06/15/2015
07/16/2015
11/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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