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MAUDE Adverse Event Report

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CYBERONICS, INC. VNS THERAPY LEAD BIPOLAR LEAD   Back to Search Results
Model Number 302-20
Event Date 11/01/2003
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative

Device manufacturing records were reviewed. Vns therapy labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

 
Event Description

Vns patient had pulled lead wire out from the neck incision. It is not known whether they pulled the lead completely out. The patient has been referred to neurosurgeon for follow-up. The patient has a history of mrsa and had recently experienced a flare up. The patient is reportedly hospitalized for treatment of mrsa.

 
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Brand NameVNS THERAPY LEAD
Type of DeviceBIPOLAR LEAD
Baseline Brand NameVNS THERAPY LEAD
Baseline Generic NameBIPOLAR LEAD
Baseline Catalogue NumberNA
Baseline Model Number302-20
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed06/20/2002
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key489315
MDR Report Key500547
Event Key474671
Report Number1644487-2003-00750
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2005
Device MODEL Number302-20
Device LOT Number8814
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/12/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 102 VNS THERAPY PULSE, EXPIR DATE 7/31/2005,
2,DATE OF MFG 9/30/2003, STERILIZATION LOT NO. 9273.
 
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