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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 09/13/2006
Event Type  Malfunction  
Event Description

The physician reported that the patient began to deteriorate after about a month and a half without magnetic activation. The physician noted that the output current has been pushed up to the patient's pre-op dose of 2. 5ma. The patient was reported to be tolerating the increase well and is now improved.

 
Manufacturer Narrative

\ the information included in follow-up mfr. Report #1 was inadvertently reported as this was not related to the report. Please disregard that information as it does not pertain to this reported event.

 
Event Description

During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2006. The physician corrected the settings; however, the magnet output current was not corrected. No patient adverse events were reported.

 
Manufacturer Narrative

Review of the available programming and diagnostic 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 Key3905146
Report Number1644487-2014-01641
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/04/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number364708
OTHER Device ID NumberMODEL 7.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/06/2005
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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