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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 02/20/2013
Event Type  Malfunction  
Event Description

Vns programming history was received from the reporter and reviewed by the manufacturer. The dates range from 04/27/2009 to 03/26/2013. The last settings on (b)(6) 2013 are 2ma/20hz/250pulsewidth/30sec on/1. 8min off/2. 25ma mag/500pulsewidth/60sec on. The last magnet mode diagnostics were on (b)(6) 2009, ok/ok/1ma delivered/2827 ohms. The last diagnostics were on (b)(6) 2013, systems, output status = ok, lead impedance = ok, 2ma delivered/2417 ohms/ok. Per the history, no magnet mode diagnostics were done on (b)(6) 2013, which was when the reporter stated magnet mode testing was performed. Six diagnostics tests were done on (b)(6) 2013; 3 faulted normal mode tests and 3 successful systems tests only. Magnet history documents 2 magnet swipes were detected on (b)(6) 2013, which was when the reporter indicated she was doing the magnet swipes. The swipes consistently increase in the history, which is an expected event.

 
Event Description

Reporter indicated that a patient's vns magnet swipes were not being detected during magnet mode diagnostics testing. The patient did feel magnet mode stimulation, but this was not reflected in the magnet history during magnet mode diagnostics testing. The magnet was tested on a metal object and appeared to have appropriate magnetic strength. Review of available programming history for the patient revealed the magnet swipes show regular increases. Attempts for additional vns programming history are in progress.

 
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3015741
Report Number1644487-2013-00762
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874817
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/10/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2011
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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