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MAUDE Adverse Event Report

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CYBERONICS NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 05/08/2002
Event Type  Death   Patient Outcome  Death;
Event Description

Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death cetificate indicates that pt died while hospitalized. Immediate cause of death is listed as sudden cardiac death, due to or as a consequence of myocardial infarction. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

 
Manufacturer Narrative

H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number101
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 Marketed02/01/2000
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd.
suite 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key507989
MDR Report Key518958
Event Key492450
Report Number1644487-2004-00257
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2002
Device MODEL Number101
Device LOT Number3359
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/05/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2001
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: 04/04/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-30 NCP BIPOLAR LEAD, EXPIR DATE 11/30/99
2,DATE OF MFG 11/25/97, STERILIZATION LOT NO. 5625C.
3,IMPLANTED 1998.
 
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