• 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 06/15/2012
Event Type  Malfunction  
Event Description

A vns consultant was at a clinic, and it was reported that their handheld computer was not holding a charge. The consultant could not get the handheld computer to turn on even with it plugged in. It was verified that the lock button was not on, and that a hard reset did not bring up the screen. The programming system is kept in the normal office environment temperature. The handheld was returned, and analysis is pending completion.

 
Event Description

The handheld computer was received with a v8. 0 flashcard and with the main battery depleted. The handheld was received without an ac adapter and serial cable. The handheld device was powered using a known good ac power supply with no anomalies from inhouse. The handheld's main battery was fully recharged successfully using the power supply adapter from inhouse. The power button light on the handheld computer was amber and then later turned green giving the indication that the main battery was fully charged. The back-up battery indicator read "normal". This is an indication that the backup battery also was recharged successfully. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. It is likely that their was an issue with the ac adapter cord charging the handheld at the office. The cord was discarded, therefore will not be returned for analysis.

 
Manufacturer Narrative

 
Manufacturer Narrative

Event likely related to discarded ac adapter cord failure. Device malfunction suspected with ac adapter cord that was not returned and discarded.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2640276
Report Number1644487-2012-01690
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874811
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/20/2012
Event Location Other
Date Manufacturer Received07/20/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/23/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-