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MAUDE Adverse Event Report

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 12/12/2002
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 manufacturer's current procedures. In an effort to obtain additional info regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by the mfr. Death certificate indicates that pt died while hosptialized. Immediate cause of death is listed as cardiopulmonary arrest. No autopsy was performed. 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 cause or contributed to the patient's death, it cannot be definitively ruled out as a factor.

 
Manufacturer Narrative

Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. 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, 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 Key499084
MDR Report Key510117
Event Key483941
Report Number1644487-2004-00096
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative,Other
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2002
Device MODEL Number101
Device LOT Number1353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2000
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: 02/05/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-30 NCP BIPOLAR LEAD. EXPIR 09/30/2002,
2,DATE OF MFG 10/06/2000, STERILIZATION LOT NO. 962.
 
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