• 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 104

  • 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 104 Back to Search Results
Model Number 104
Event Date 07/27/2010
Event Type  Injury  
Event Description

Reporter indicated a vns pt had an infection at the generator and electrode sites. The vns generator and lead were removed, and a new generator and lead were placed in the pt's right chest and right vagus nerve. The cause of the infection was unk. Cultures of the generator chest pocket resulted in pseudomonas and (b)(4) bacteria. No trauma or device manipulation occurred. Antibiotics were also given as an intervention for the infection. The pt did not show for his post-operative office appointment, and attempts to contact the pt for further eval by the office have been unsuccessful to date.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1842099
Report Number1644487-2010-02134
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2010
Device MODEL Number104
Device LOT Number200859
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/16/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2008
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: 09/20/2010 Patient Sequence Number: 1
-
-