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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/01/2010
Event Type  Injury  
Event Description

It was initially reported that the pt was experiencing an infection at the generator site following the replacement of the generator. It was noted that the nurses at the pt's group home noted redness and infection signs at the operation site on pt's chest. There was also mention of wound dehiscence, which was later resolved. The pt's generator was then removed and treated with vancomycin due to the confirmed presence of (b) (6). There was no known pt manipulation. The pt is expected to have his device replaced. No further details have been made on the event.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1631441
Report Number1644487-2010-00616
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2010
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 Number102
Device LOT Number201152
Was Device Available For Evaluation? No
Date Manufacturer Received03/05/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2009
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: 03/12/2010 Patient Sequence Number: 1
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