• 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 Failure to Interrogate ; Failure to Power Up
Event Date 08/31/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

On (b)(6) 2015, it was reported that the physician's handheld will not turn on despite being plugged into a known to be working outlet. The problem was noted to have begun two weeks prior and multiple patients were unable to be interrogated. The handheld and flashcard were returned for product analysis on (b)(4) 2015. Product analysis is still underway and has not yet been completed.

 
Event Description

On (b)(6) 2015 product analysis was completed on the handheld and flashcard. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the serial cable was providing power to the handheld intermittently. The cause for the anomaly is associated with an open electrical connection in the power cable portion. As a result of the open wire connection, the handheld would receive power from the ac adapter intermittently. No other anomalies were identified. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
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
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 Key5137698
Report Number1644487-2015-06057
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 09/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1063830
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-