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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Device Problems Device Inoperable (1663); Computer Operating System Problem (2898); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2016
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
It was reported that the programming computer does not work anymore.It no longer recognizes the usb serial cable.It was reported that the usb cable was replaced, but nothing changed.The programming wand used with the tablet was checked and confirmed to be working fine.It is suspected that the usb serial cable connector to the tablet is faulty.Review of manufacturing records confirmed all tests passed for the device prior to distribution.Return of the programming computer for analysis is expected, but it has not been received to date.
 
Event Description
The suspect programming computer was received by the manufacturer on 09/26/2016.An analysis was performed on the returned tablet and the reported allegation was not verified.No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.The tablet performed according to functional specifications.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING COMPUTER
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 Key5959274
MDR Text Key55426174
Report Number1644487-2016-02114
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2016
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
Other Device ID NumberVERSION 11.0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2016
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 08/24/2016
Initial Date FDA Received09/19/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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