• 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 PROGRAMMING COMPUTER

  • 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 PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 08/22/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's wand was not working properly. A known working wand was used with the physician's programming computer and worked. It was reported that the wand data received light would not illuminate. The physician's office was provided a new wand and the wand was returned for analysis. Analysis of the wand was completed on 09/09/2014. Analysis confirmed the integrity of the serial data cable continuity was not compromised by the dislodged strain-relief grommet. Internal visual inspection found the j1/p1 connections were intact. It is not known why the strain relief grommet became dislodged from its intended location. Although there was a visual anomaly with the strain relief grommet, the programming wand performed according to functional specifications. It is unknown if the physician's computer serial cable was used when the troubleshooting was performed and whether or not the system is working with the new wand. No additional relevant information has been received to date.

 
Manufacturer Narrative

 
Event Description

Additional information received revealed that the programming system is functioning properly with the new programming wand.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4153134
Report Number1644487-2014-02592
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-