• 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 07/23/2008
Event Type  Malfunction  
Event Description

Reporter indicated a vns wand failed to program pts. The vns wand was returned for product analysis. Analysis revealed that the wand serial data cable, which produced communication errors, had an open conductor. A known good bench serial data cable was submitted and all communications errors cleared.

 
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 DevicePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1111875
Report Number1644487-2008-01875
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/23/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2008
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? Yes
Date Returned to Manufacturer07/28/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/23/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1999
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-