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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 10/19/2009
Event Type  Injury  
Event Description

Reporter indicated a patient developed a superficial infection and wound dehiscence at the vns generator incision site and was hospitalized for five days. The patient received intravenous vancomycin and oral antibiotics. The causative organism was possibly coagulase negative staphylococcus aureus. The patient has finally recovered from the infection. The cause of the infection is unknown per the reporter.

 
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
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1532686
Report Number1644487-2009-02573
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number201043
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/19/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 11/17/2009 Patient Sequence Number: 1
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