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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 10/13/2010
Event Type  Malfunction  
Event Description

During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010, the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010. The physician corrected the settings; however, the magnet on time was not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet on time back to the previous setting. No patient adverse events were reported.

 
Manufacturer Narrative

Analysis of programming history.

 
Manufacturer Narrative

Serial #, corrected data: previously submitted mdr inadvertently did not provide the correct serial number of the suspect device. It is now known. This report is being submitted to correct this data. Lot #, corrected data: previously submitted mdr inadvertently did not include this information. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr inadvertently did not include this information. This report is being submitted to correct this data.

 
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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 Key4063702
Report Number1644487-2014-02256
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type 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 Received09/05/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number678293
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2009
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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