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MAUDE Adverse Event Report

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CYBERONICS, INC. BIPOL LEAD MODEL 302   Back to Search Results
Model Number 302-20
Event Date 05/05/2008
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter indicated that vns pt had lead extrusion and infection at the electrode and generator sites. The infection had been present for some time. The infective organism was methicillin-resistant staphylococcus aureus. The pt had previously presented to the emergency room with a deep dehiscence of his cervical incision. The dehiscence resulted from a lanced blister that was a result of tracheostomy tapes near the incision site. The lead extrusion was due to the infection per the reporter. The pt's vns generator and entire lead were explanted. During the surgery, bloody pus and swelling was noted around the generator site, which was indicative of the pt causing self-trauma to the area due to pain. It is not likely the pt will be reimplanted per the reporter. The explanted generator and lead have been returned and are currently in product analysis.

 
Manufacturer Narrative

Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NameBIPOL LEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058-2017
(281) 228 -7200
Device Event Key1025665
MDR Report Key1057230
Event Key1015341
Report Number1644487-2008-01282
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1036
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/23/2008
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/05/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/13/2005
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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