• 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 08/01/2011
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012, when a copy of the physician's flashcard was received and the magnet activations were reviewed. The data was available from (b)(6) 2011 to (b)(6) 2012. The first magnet activation listed is on (b)(6) 2011, however the total at that time is 2331. On (b)(6) 2012, there are also multiple magnet activations however the number did not change from the total of 6916 that was first displayed on (b)(6) 2012. On (b)(6) 2012, it was reported that the device has been programmed off however the magnet activations increased again to 7048 even with the magnet output current being set to 0 ma. Good faith attempts to obtain additional information are currently being made. Nicole also stated pt has a lot of magnet activations and he stated he does not use his magnet and caregiver also states he does not use magnet. Pt is a little delayed so nicole is not sure. I asked if he recently got ipad or around any speakers or other devices with magnets. She stated no she did not think so. As of today pt had 6913 magnet activations and from (b)(6) 2331 magnet activations. No increase in seizures. Informed her something needs to be activating the device. She acknowledged and will ask the pt.

 
Manufacturer Narrative

Magnet activations found in the patient's programming history were reviewed.

 
Event Description

Additional information was received on (b)(6) 2012 when it was reported that the patient does not use the magnet and is not exposed to any magnets in his daily environment.

 
Event Description

It was reported that during an office visit on (b)(6) 2012 it was noted that several magnet activations were showing up however the patient stated he did not use his magnet. The patient had 6913 magnet activations on (b)(6) 2012 and 2331 magnet activations from (b)(6). There is no increase in seizures. Good faith attempts to obtain additional information including programming history to confirm the magnet activation error have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2511259
Report Number1644487-2012-00854
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/05/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874810
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-