• 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

  • 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 Back to Search Results
Model Number MODEL 250
Event Date 03/30/2011
Event Type  Malfunction  
Event Description

It was initially reported that the pt total magnet activation count was not increasing with magnet activations. The nurse reported that the pt swipes his magnet several times per week, however, the total number of magnet activation were the same in (b)(6) 2010 and (b)(6) 2011. The magnet was swiped in the office and the pt felt stimulation. After re-interrogating the pt, the total magnet activations had not increased. There is no suspected issue with the pt's generator. Good faith attempts to gain programming history are in process.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
sute 600
houston , TX 77058
2812287200
MDR Report Key2086611
Report Number1644487-2011-00923
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number840144
OTHER Device ID NumberVERISON 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/30/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-