• 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

  • 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 Back to Search Results
Model Number 201
Event Date 07/09/2008
Event Type  Malfunction  
Event Description

It was reported to manufacturer that the site was having problems interrogating vns patient's devices. Troubleshooting was performed, which included exchanging the 9v wand battery, and the problems did not resolve. The site requested a new programming wand to replaced the non-working device. Attempts to obtain additional information and the non-working device for analysis have been made, but have been unsuccessful to date.

 
Manufacturer Narrative

Device failure is suspected, 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
Manufacturer (Section D)
CYBERONICS, INC
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd. ste. 600
houston , TX 77058
2812287200
MDR Report Key1105286
Report Number1644487-2008-01837
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/09/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-