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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Device Problems Bent (1059); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the physician is having a problem with a tablet.The physician states there is a bent pin where the usb cable goes in which is causing the usb serial cable to not be able to communicate with the wand.The associated serial cable was discarded.The tablet has not been received for analysis to date.
 
Event Description
Tablet was received for analysis on 03/30/2016.Product analysis for the tablet was completed and approved on 04/20/2016.An analysis was performed on the returned tablet and 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.Visual inspection identified no anomalies.No bent pins in the usb port were identified.Two known good serial cables were tested on the tablet during initial troubleshooting which did not work on the old system.The wand was also confirmed to be functioning properly.Therefore, it is unknown what may have caused the communication issues with the tablet port.
 
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Brand Name
PROGRAMMING COMPUTER
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 Key5515342
MDR Text Key41147540
Report Number1644487-2016-00615
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/25/2016
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/25/2016
Initial Date FDA Received03/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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