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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 11/09/2009
Event Type  Malfunction  
Event Description

During review of the in-house programming/diagnostic history database, it was observed that a system diagnostic test was performed on (b)(6) 2009. Interrogation after the diagnostic test showed that the settings found were indicative of a faulted diagnostic test. The settings were corrected prior to the patient leaving the clinic, except the magnet on time. The device was not interrogated prior to the patient leaving the office as recommended by device manufacturer to ensure the device is at the correct settings. No patient adverse events were reported.

 
Event Description

An interrogation was performed following the change in settings after which physician re-programmed device settings; however, not all settings were returned to their previous values.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr indicated that the device was not interrogated prior to the patient leaving the office to ensure the device is at the correct settings; however, an interrogation was performed following the change in settings after which physician re-programmed device settings. Relevant tests/laboratory data, including dates, corrected data: the settings to which the device was reprogrammed on the date of the change in settings was inadvertently omitted from the previous mdr. Lot #, other, corrected data: previously submitted mdr indicated that these items were unknown. They are now known. Name and address, corrected data: previously submitted mdr indicated an incorrect initial reporter. Occupation, corrected data: previously submitted mdr indicated an incorrect initial reporter. Device manufacture date (mo/day/yr), corrected data: previously submitted mdr indicated that this was unknown. They is now known.

 
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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 Key4054830
Report Number1644487-2014-02176
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 Received09/03/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number521397
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/09/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/08/2007
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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