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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 07/03/2012
Event Type  Injury  
Event Description

It was reported that after a vns implant, a patient presented with signs of cellulitis in the skin of demipulse pocket. The procedure of implantation was on (b)(6) 2012. Blood cultures were taken and antibiogram and the patient stayed in the hospital for 7 days with vancomycin via iv. They were also taking diclosil an oral medication for 7 days. The patient's implanting surgeon felt the event was related to surgery since occurred less than 10 days after surgery. No patient trauma or manipulation was reported prior to the event. The results of the patient's cultures were negative and their antibiotic treatment was prophylactic. The patient finished their antibiotic treatment and their cellulitis resolved.

 
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 DevicePULSE GEN MODEL 103
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2659844
Report Number1644487-2012-01813
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number103
Device LOT Number202064
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/05/2012
Event Location Other
Date Manufacturer Received07/05/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/29/2012
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: 07/18/2012 Patient Sequence Number: 1
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