• 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 WAND NONE

  • 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 WAND NONE Back to Search Results
Model Number 201
Event Date 09/03/2008
Event Type  Malfunction  
Event Description

It was reported that a cyberonics rep was unable to get his wand to work. He performed routine troubleshooting and changed the battery; however, the wand would not work. He used a different programming system and everything worked fine. He also used his handheld device with a different wand and everything worked fine. The product has been received by the mfr for analysis; however, it has not been completed at the time of this report.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING WAND
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1191917
Report Number1644487-2008-02374
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/03/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/19/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received09/03/2008
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-