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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. NCP PULSE GENERATOR PULSE GENERTOR

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CYBERONICS, INC. NCP PULSE GENERATOR PULSE GENERTOR Back to Search Results
Model Number 101
Event Date 03/25/2004
Event Type  Death  
Event Description

Reporter indicated that vns patient had passed away. It was reported that the patient was walking into a room and simply dropped dead. Treating neurologist indicted that the death may be cardiac-related, but is not sure as autopsy results are pending. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

 
Manufacturer Narrative

Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. H. 6 device manufacturing records were reviewed. Review of manufacturing records for both the pulse genertor and the bipolar lead revealed no anomalies that would adversely effect device performance.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERTOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
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 F)
CYBERONICS, INC.
100 cyberonics blvd.
ste. 600
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonic blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key511173
MDR Report Key522043
Event Key495415
Report Number1644487-2004-00357
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,Other
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2004
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 Number1258
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2004
Was Device Evaluated By Manufacturer? No
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: 04/23/2004 Patient Sequence Number: 1
Treatment
MODEL 300-20 NCP BIPOLAR LEAD,
EXPIR DATE 10/31/2002, DATE OF MFG 11/07/2000,
STERILIZATION LOT NO. 1315.
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