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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. DEMIPULSE GEN MODEL 104

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CYBERONICS, INC. DEMIPULSE GEN MODEL 104 Back to Search Results
Model Number 104
Event Date 12/01/2009
Event Type  Injury  
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

It was initially reported by the surgeon that the patient developed an infection at the generator site after her second re-implant surgery. Patient was treated with antibiotics for a few days and then, the surgeon performed a generator replacement surgery. Patient was re-implanted with a new generator on the right side of the chest since the surgeon did not want to place the new generator back into the old pocket. Diagnostics were performed prior to replacement surgery, and it showed everything working within normal limits. Good faith attempts to obtain additional information has been unsuccessful.

 
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Brand NameDEMIPULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd. ste. 600
houston , TX 77058
2812287200
MDR Report Key1567252
Report Number1644487-2009-02878
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/11/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number104
Device LOT Number201114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/11/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2009
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: 12/23/2009 Patient Sequence Number: 1
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