• 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 102R

  • 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 102R Back to Search Results
Model Number 102R
Event Date 05/03/2011
Event Type  Injury  
Event Description

Reporter indicated the patient did not have a pre-vns history of an arrhythmia, but an arrhythmia was not confirmed. The reporter referred all additional questions to the treating surgeon. All attempts for further information regarding the possible arrhythmia from the surgeon have been unsuccessful to date.

 
Event Description

Reporter indicated via clinical notes received to the manufacturer that a vns patient had a possible arrhythmia. The patient was prescribed a holter monitor for use at home to analyze his heart rhythm on (b)(6) 2011. All attempts for additional information from the reporter regarding the possible arrhythmia have been unsuccessful to date.

 
Event Description

Additional information was received to the manufacturer from the treating surgeon. Per the treating surgeon, the patient did not have an arrhythmia. No additional information was provided.

 
Manufacturer Narrative

 
Manufacturer Narrative

Information from the reporter was inadvertently omitted from the initial mdr report.

 
Event Description

Reporter indicated via clinic notes received to the manufacturer on (b)(6) 2012 that the patient had increased seizures on (b)(6) 2011. The patient had been seizure-free for two years, and then had 3 seizures on (b)(6) 2011 that were suspected to be drop seizures. Vns diagnostics were within normal limits and the vns was not at end of service. The patient had ans testing (study of the sympathetic and parasympathetic nervous system) performed, which was abnormal. Attempts for further information regarding the increased seizures have been unsuccessful to date.

 
Manufacturer Narrative

Information from the reporter regarding the increased seizures was inadvertently omitted from the initial mdr report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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 Key2556909
Report Number1644487-2012-01122
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/06/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2009
Device MODEL Number102R
Device LOT Number1991
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/07/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2008
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: 05/02/2012 Patient Sequence Number: 1
-
-