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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 11/30/2007
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter indicated a vns patient picked at the incision site where the generator was and it began to protrude. The patient's generator became infected and the generator was explanted. The hospital no longer has the generator; therefore, a product analysis will not be performed. The patient will be reimplanted as he did well with vns. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1038536
MDR Report Key1069916
Event Key1027947
Report Number1644487-2008-01537
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2008
Device MODEL Number102
Device LOT Number016065
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/03/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2006
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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