• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS 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 PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 08/01/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2887104
Report Number1644487-2012-03459
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/27/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2013
Device MODEL Number103
Device LOT Number201761
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/27/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/02/2011
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: 12/27/2012 Patient Sequence Number: 1
-
-