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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 09/09/2010
Event Type  Injury  
Event Description

Reporter indicated a vns pt's generator site wound had dehiscence and was causing pain, and required additional surgery to close the incision site. F/u with the reporter revealed the dehiscence and pain were due to the suture being placed incorrectly under the pt's skin, and not to the vns device itself. The pain resolved after the incision site was re-sutured. Attempts for vns implant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1869525
Report Number1644487-2010-02246
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/09/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/06/2010 Patient Sequence Number: 1
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