• 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 09/22/2014
Event Type  Malfunction  
Event Description

Analysis of the handheld was completed on 11/07/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the handheld would not power on. The cause for the anomaly is associated with fluid damage on the main pcb. Once the pcb was replaced, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Analysis of the flashcard was completed on 11/07/2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Event Description

It was reported that the physician's handheld will not charge. The physician left the handheld plugged into the electrical outlet for four straight days and it still would not charge. The battery was removed and reinserted, but this did not resolve the issue. The physician was provided a new programming computer. The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

 
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 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 Key4210382
Report Number1644487-2014-02877
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1063528
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/09/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/07/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-