• 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 103 GENERATOR

  • 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 103 GENERATOR Back to Search Results
Model Number 103
Event Date 03/19/2013
Event Type  Malfunction  
Event Description

It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3414002
Report Number1644487-2013-03237
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/30/2014
Device MODEL Number103
Device LOT Number202150
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-