• 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
Device Problems Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2014
Event Type  malfunction  
Event Description
It was reported that the serial cable for the handheld device was causing intermittent communication issues due to a loose connection.Troubleshooting was performed and determined the root cause of the issues was the serial cable.The serial cable has not been returned to date.
 
Event Description
Analysis of the returned handheld serial cable was completed.No anomalies associated with the serial cable communication were identified during the analysis.However, it was identified that the serial cable had 2 open electrical connections in the power plug wire.Because of the open wire connections, the ac adapter was unable to supply power to the handheld.No further anomalies were identified.
 
Event Description
The handheld serial cable was received for analysis.Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING 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 Key3926575
MDR Text Key4580371
Report Number1644487-2014-01751
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 250
Device Lot Number1063829
Other Device ID NumberVERSION 8.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2014
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 08/25/2014
Initial Date FDA Received07/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/14/2014
09/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-