• 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

  • 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 Back to Search Results
Model Number 102
Event Date 09/05/2011
Event Type  Injury  
Event Description

Further information from physician reveals that the infection was believed to be due to vns, but patient manipulation or trauma occurred "immediately post op" that may have contributed to the infection. No cultures of the would were taken. The patient was put on antibiotics and the issue resolved.

 
Event Description

It was reported that one week after the vns implanted surgery, the pt had redness and swelling at the generator site. He tried cleaning the wound, and on the day he was supposed to go for a follow-up visit with his neurologist, it appeared that the wound was opening up. On the same day, the physician referred the pt back to the surgeon. The pt was put on antibiotics. The pt explains that he saw the surgeon and was told the infection is getting better, and the pt can return to "light" or "limited" work. Attempts for further information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 7705 8
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 Key2307851
Report Number1644487-2011-02510
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2012
Device MODEL Number102
Device LOT Number2701
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/16/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2010
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: 10/19/2011 Patient Sequence Number: 1
-
-