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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/19/2008
Event Type  Injury  
Event Description

Reporter indicated a pt's vns generator and lead were explanted due to infection. The pt presented with dehiscence and serous drainage at the generator incision site. The pt also had pain and erythema at the neck incision site. During the explant surgery, dark turbid fluid was noted in the generator pocket. The dark drainage fluid was cultured and the causative organism was staphylococcus aureus. The pt was also placed on 500mg ciprofloxacin twice daily by mouth. The pt has fully recovered and will likely be reimplanted with vns in 4-6 months. Reporter indicated the pt had no trauma and did not manipulate the vns. The cause of the infection was the implant surgery per the reporter.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1314355
Report Number1644487-2009-00303
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/28/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2010
Device MODEL Number103
Device LOT Number200905
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/28/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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: 02/17/2009 Patient Sequence Number: 1
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