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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 09/20/2007
Event Type  Injury  
Event Description

Reported indicated that after initial vns implant surgery on (b)(6) 2007, the incision site "opened up almost all the way" and that she had "a superficial infection" due to the "surgical glue" used on her incision. Attempts to the implanting surgeon for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Method - device manufacturing records were reviewed. Results - review of manufacturing 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 Key1805148
Report Number1644487-2010-01864
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/20/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2008
Device MODEL Number102
Device LOT Number016488
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/20/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2007
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: 08/13/2010 Patient Sequence Number: 1
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