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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE
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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Device Problems Difficult to Interrogate (1331); Failure to Read Input Signal (1581)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2016
Event Type  malfunction  
Event Description
A physician stated that he was having trouble interrogating patients with his tablet.The physician start interrogating the button was not responding to touch.No information regarding whether or not patient therapy was impacted was provided.No further additional relevant information has been received to date.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS
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 Key6178776
MDR Text Key62865570
Report Number1644487-2016-02879
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 Physician
Type of Report Initial
Report Date 11/21/2016
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 11/21/2016
Initial Date FDA Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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