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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 06/23/2010
Event Type  Malfunction  
Event Description

It was reported by a company rep that a pt's magnet activation display was out of order. The list of activations, normally displayed in descending chronological order, had the following order: (b)(6) 2011 again. Furthermore, the pt was interrogated at 1. 75 ma/20 hz/500 ms/21 sec/0. 8 min, but the pt's pulse width should have been 250 microsec. The rep stated she believed the pt was accidentally set to the 500 microsec value. Attempts for further info have been unsuccessful to date.

 
Event Description

Additional programming history was received that confirmed that the patient was programming to 500 usec.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 7705 8
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 Key2117978
Report Number1644487-2011-01164
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup
Report Date 05/02/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number584958
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Date Manufacturer Received04/16/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2008
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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