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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 250
Event Date 02/28/2012
Event Type  Malfunction  
Event Description

A vns treating physician reported that when he was looking at the device history, he noticed that the magnet activations looked weird. He described that the last 15 magnet activations were all the same times but the last time would be left off on the next line and so on. Good faith attempts are underway to see if this is part of a magnet activation display error.

 
Event Description

Programming history was received for review. It was noted that the patient's generator had rolled over on (b)(6) 2011 and would have likely attributed to their report of the magnet activation display error although not seen in the history provided. Per the available data the patient had not used their magnet since (b)(6) 2009.

 
Manufacturer Narrative

Type of report corrected data; omitted on initial report, 30 day report. Analysis of magnet activation history performed.

 
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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 Key2494047
Report Number1644487-2012-00734
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number841226
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/02/2012
Event Location Other
Date Manufacturer Received07/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2010
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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