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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 06/25/2010
Event Type  Injury  
Event Description

Reporter indicated a vns pt who is developmentally delayed picked at the generator site incision one week after generator replacement surgery and developed wound dehiscence. The wound was cleaned and re-stitched; after one month, the pt developed wound dehiscence again and an infection at the generator site. Pt manipulation of the incision site was not believed to be a cause of the infection the second time the wound underwent dehiscence. The reporter indicated the infection and wound dehiscence are due to the vns. Explant of the vns generator appears likely. Further attempts for information are in progress.

 
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 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1870802
Report Number1644487-2010-02272
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2011
Device MODEL Number102
Device LOT Number2561
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/13/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
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: 10/11/2010 Patient Sequence Number: 1
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