Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

MAUDE Adverse Event Report

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 

CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 04/24/2003
Event Type  Death   Patient Outcome  Death;
Manufacturer Narrative

Further follow-up revealed that an autopsy was not performed. Physician indicated that the patient's death was "probably" sudep. The patient was found dead in the morning. Physician indicated that the ncp system was not related to the cause of death.

 
Manufacturer Narrative

Report is incomplete because attempts to obtain add'l info have been unsuccessful to date. No response has been received to mfr's requests for add'l info from treating neurologist. H. 6. Device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

 
Event Description

Reporter indicated that vns pt had passed away. Exact cause of death is unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key453161
MDR Report Key464220
Event Key439899
Report Number1644487-2003-00308
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2004
Device MODEL Number101
Device LOT Number7310
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/07/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2002
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: 06/06/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-20 NCP BIPOLAR LEAD,
2,EXP DATE 9/30/2001,
3,DATE OF MFG 9/23/1999,
4,STERILIZATION LOT NO. 29042C.
5,MEDICATIONS AT TIME OF DEATH:
6,VALPROATE/VALPROIC ACID, TOPIRMATE.
 
-
-
-
-
-