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MAUDE Adverse Event Report

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CYBERONICS, INC. CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR   Back to Search Results
Model Number 100
Event Date 06/05/1998
Event Type  Death   Patient Outcome  Death;
Manufacturer Narrative

Field report: pt death reported. Stated not related to device. Pt death follow-up form: physician reports believed relationship between the ncp system and cause to be unk, but "likely sudep".

 
Event Description

Describe event or problem: pt death.

 
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Brand NameCYBERONICS NEUROCYBERNETIC PROSTHESIS
Type of DeviceNEUROSTIMULATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number100
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)18
Date First Marketed07/16/1997
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd #600
houston TX 77058 2017
Manufacturer Contact
annette zinn
16511 space center blvd
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key307609
MDR Report Key318091
Event Key299069
Report Number1644487-2001-00148
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/05/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/24/1998
Device MODEL Number100
Device LOT Number3969C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/05/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/1997
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: 02/23/2001 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-20 BIPOLAR LEAD.
 
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