• 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 250
Event Date 11/21/2008
Event Type  Malfunction  
Event Description

It was reported that a dell handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. Follow-up revealed that the anomaly was no longer visible in the handheld. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr[255]) being mis-declared as static variable, however, the trigger for this vent has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1431141
Report Number1644487-2009-00932
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/30/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number584960
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-