• 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. LEAD MODEL 302

  • 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. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 02/25/2013
Event Type  Injury  
Event Description

It was reported that the patient had increase in depression. After communication with the physician assistant on (b)(6) 2013, the physician stated that the patient had increase in depression and no longer feels the stimulation because her voice alteration went away. It was then determined that the patient had pain in her back and caused her to be depressed more as a result. Depression levels are below pre-vns baseline. The patient used to have voice alteration but no longer experience it because the surgeon injected the patient with collagen into her vocal cords and the voice alterations went away. The physician also stated the possibility that the patient's voice alteration went away because she was implanted for a while with the same settings. Attempts for additional questions are underway.

 
Event Description

Attempts were made for additional questions regarding the patient's vocal cords. The physician replied by stating that he does not manage vocal cords. The physician referred to another physician who managed the patient's vocal cords to have the questions sent to, but the other physician is deceased.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3056134
Report Number1644487-2013-01004
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup,Followup
Report Date 03/14/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number302-20
Device LOT Number1137
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2005
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: 04/12/2013 Patient Sequence Number: 1
-
-