• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 12/01/2010
Event Type  Malfunction  
Event Description

It was reported that the manufacturer representative's handheld battery was not charging and that the ac adapter cord had to be held in a specific position for the device to charge. The handheld computer, software flashcard, and the ac adapter cord are en route to the manufacturer headquarters where analysis will be performed.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to death or serious injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1984755
Report Number1644487-2011-00131
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 12/28/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMODEL 250
Device LOT Number715906
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/28/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-