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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/25/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a vns implanting surgeon reported that the vns patient had an infection at the generator site and was scheduled to have his device explanted on (b)(6) 2012. The patient's mother first observed the infection on (b)(6) 2012 when she lifted the patient's shirt and saw the infection. The patient was known for picking at the generator site often. The patient was given antibiotics on (b)(6) 2012. Clinic notes dated (b)(6) 2012 were received. The patient presented with an open sore over the previous vns generator site that developed 3-4 days ago although, it was not noticed by the patient's mother until 1 day ago. The patient did not have a cellulitis fever or an extension of tenderness up the lead path to the neck. The patient's seizures were reported to be reasonably controlled on oral anti-seizures meds. The physician noticed a breakdown with granulation tissue, chronic, with a visible suture at the vns generator site. There was dehiscence at the vns generator site. The clinic notes stated that the patient was going to have iv antibiotics and removal of the vns generator and possibly the leads. The manufacturer's consultant later confirmed that the infection was due to the patient picking at the generator site. The generator and lead were removed on (b)(6) 2012. The surgeon noticed "pus" in the lead so he cut some of it out. Cultures were taken which confirmed the infection was staph aureus and was susceptible to antibiotics. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key2493210
Report Number1644487-2012-00726
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/29/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number103
Device LOT Number3038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/29/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2011
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: 03/15/2012 Patient Sequence Number: 1
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