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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
Event Date 06/05/2002
Event Type  Malfunction  
Manufacturer Narrative

Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently provided an incorrect date for the faulted system diagnostic test.

 
Event Description

On (b)(6) 2014 during a review of programming history, it was observed that a system diagnostic test occurred on (b)(6) 2002 which resulted in a settings change. All settings were not corrected prior to the patient leaving the office visit; the magnet output was inadvertently left at the incorrect settings of output=1ma.

 
Manufacturer Narrative

Analysis of programming history.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4061664
Report Number1644487-2014-02234
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2014
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
Date Manufacturer Received09/16/2014
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 Invalid Data

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