• 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 102 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 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/22/2014
Event Type  Injury  
Event Description

The patient began experiencing painful stimulation in the throat on (b)(6) 2015. Diagnostic results were checked and within normal limits. The patient did not experience any trauma or manipulation that may have contributed. On 06/16/2015 the patient reported that he is planned to have his vns removed and he had a consultation that day in which the physician agreed to the removal. The patient noted that he was planning to have the device removed due to being unable to breathe associated with stimulation. He also has coughing and throat pain associated with vns stimulation. He noted that his diagnostic results, both systems and normal were fine and within range. Follow-up with the physician was unclear on whether the explant is for patient comfort or to preclude a serious injury. Further attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received on 07/16/2015 from the physician's office. The nurse indicated that the patient's generator was disabled a couple of months prior due to the throat pain he was experiencing. No recent diagnostics were available to provide but it was stated that the device was functioning normally a few months ago. The plan for the patient is to keep the device disabled and try to get him set up for removal of the device although this is not planned to date. She said that the disablement and surgery is both for comfort and to possibly prevent a serious injury from the pain. The patient complained of severe pain in the throat area with stimulation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4919084
Report Number1644487-2015-05208
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 06/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015227
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2006
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: 07/16/2015 Patient Sequence Number: 1
-
-