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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 06/19/2013
Event Type  Injury  
Event Description

The patient's vns device was removed due to infection at the site. The infection was first observed on (b)(6) 2013. A wound swab from the left neck wound indicated staphylococcus aureus. This was treated with antibiotics. On (b)(6) 2013, there was revision and cleaning of the left axilla wound. Inflammatory exudate seen, but no pus observed. Treated with antibiotics. (b)(6) 2013 - inflammation of the left axilla wound. A wound swab showed staphylococcus aureus. The vns generator and lead were removed on (b)(6) 2013. Cloudy fluid was seen, but there was no obvious pus. Heavy growth of staphylococcus aureus seen and treated with antibiotics. The medical professional stated that the relationship of the infection to vns was likely an external cause. No patient manipulation or trauma was noted. The anatomical location of the infection was not thought to be a factor. Cultures confirmed staphylococcus aureus. No other information was provided.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3538529
Report Number1644487-2013-03915
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL Number103
Device LOT Number202312
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2012
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: 12/26/2013 Patient Sequence Number: 1
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