• 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 07/14/2008
Event Type  Malfunction  
Manufacturer Narrative

Device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Initial reporter indicated that they were at a physicians office testing out their new programming system and "she couldn't get the dell x50 handheld computer turn on event when plugged into the wall". When plugged into the wall, the power light did not light up and the lock button was not in the red position. A hard reset and soft reset was performed and the handheld did not turn on. The handheld was returned for analysis with 7. 1 programming software. Both products went through product analysis and no anomalies were identified against the handheld or software performance. The handheld was returned without the ac adapter therefore a malfunction is suspected against the ac adapter. Good faith attempts have been made for product return.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key1148007
Report Number1644487-2008-02004
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/06/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number250
Device LOT Number537101
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/06/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/23/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-