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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 surgeon that the pt was going to have a new generator placed soon as the last one was removed due to infection. The surgeon wanted to wait until infection cleared up before replacing. Surgeon notes stated that the pt had a wound dehiscence a few weeks after he had his vns battery replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till 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 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 Key1943814
Report Number1644487-2010-02898
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/30/2011
Device MODEL Number103
Device LOT Number201292
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/30/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2009
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: 12/28/2010 Patient Sequence Number: 1
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