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MAUDE Adverse Event Report

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CYBERONICS, INC. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 12/31/2008
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that a vns pt was explanted due to an infection that was developed due to pt manipulation. Further info received from the treating neurologist indicated the pt picked at the implant site and pulled the lead out, causing an infection. Furthermore, cultures were taken and the developed infection was reported in the left chest pocket.

 
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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
(281) 228 -7200
Device Event Key1544818
MDR Report Key1487309
Event Key1342219
Report Number1644487-2009-02165
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/2009
Device MODEL Number102
Device LOT Number017112
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received09/21/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

 
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