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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. DEMIPULSE GENERATORS

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CYBERONICS, INC. DEMIPULSE GENERATORS Back to Search Results
Model Number 103
Event Date 08/08/2011
Event Type  Injury  
Event Description

It was reported that the pt's wound was not healing and had opened. The pt was admitted to the hospital as a result and had her vns generator explanted. Review of the device history record confirms sterilization of the generator prior to distribution. Attempts for further information have been unsuccessful to date.

 
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 NameDEMIPULSE GENERATORS
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2246587
Report Number1644487-2011-02099
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2013
Device MODEL Number103
Device LOT Number201757
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/08/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2011
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: 09/07/2011 Patient Sequence Number: 1
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