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MAUDE Adverse Event Report

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CYBERONICS, INC. CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR   Back to Search Results
Model Number 300-20
Event Date 07/17/2001
Event Type  Injury   Patient Outcome  Hospitalization;
Event Description

Reporter indicated that patient picked at neck incision site in the pt's sleep and pulled lead off the nerve, out of the generator, and out through the neck incision. The patient's family members discarded the lead. Revision surgery was performed in 2001 and a new lead was implanted.

 
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Brand NameCYBERONICS NEUROCYBERNETIC PROSTHESIS
Type of DeviceNEUROSTIMULATOR
Baseline Brand NameNCP BIPOLAR LEAD
Baseline Generic NameBIPOLAR LEAD
Baseline Catalogue NumberNA
Baseline Model Number300-20
Baseline Device FamilyNA
Baseline Device PMA NumberK970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed10/09/1997
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd.
suite 600
houston TX 77058 2017
Manufacturer Contact
darlene garner, rac
16511 space center blvd
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key342737
MDR Report Key353517
Event Key333067
Report Number1644487-2001-00518
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/23/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2003
Device MODEL Number300-20
Device LOT Number2167
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/21/2001 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 101 NCP GENERATOR.
 
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