• 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. PULSE GEN MODEL 101

  • 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. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 06/23/2011
Event Type  Injury  
Event Description

It was reported by the patient's mother that the patient had an increase in seizures. The patient had not been seen by a physician since 2008, and the mother felt the device was no longer working. The patient was in attempts to obtain a replacement surgery. A review of the manufacturer's programming history showed the patient's last known settings and diagnostics were on (b)(6) 2007. The device was properly functioning at this time. A revision surgery in the future is likely. Attempts for further information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2196483
Report Number1644487-2011-01741
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number101
Device LOT Number7151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/06/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/03/2011 Patient Sequence Number: 1
-
-