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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. DEMIPULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 10/01/2010
Event Type  Injury  
Event Description

It was initially reported by the patient's caregiver that the patient was recently implanted with a vns device and was taken into surgery again as her incision site opened up. Patient was taken to the surgeon and infection was noted. There was a clear, yellow liquid leaking out of her generator pocket. The surgeon cleaned the incision site and taped it up. Add'l info was received from the caregiver stating that the patient was taken into a second surgery as the incision site opened up again. Good faith attempts to obtain add'l info has been unsuccessful til date.

 
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Brand NameDEMIPULSE 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 Key1910672
Report Number1644487-2010-02652
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number103
Device LOT Number2637
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
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: 11/22/2010 Patient Sequence Number: 1
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