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MAUDE Adverse Event Report

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Event Date 12/01/2001
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention
Manufacturer Narrative

The following dates are estimated. Only the month/year is known: b. 3, date of event. D. 7, implant date.

 
Event Description

Reporter indicated that pt experienced an increase in seizure activity with the vns. It was reported that the pt's usual pattern was a cluster lasting 1 1/2 days every 3 weeks. Following the vns implant, the pt's clusters occurred every 8 days. When the vns was programmed to off, the pt's seizure frequency returned to every 3 weeks. When the vns was programmed back on, the pt's seizure frequency again increased to every 8 days. Attempts to obtain additional info have been unsuccessful to date.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd., #600
houston TX 77058
Manufacturer Contact
darlene garner, rac
16511 space center blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key386683
MDR Report Key397636
Event Key375730
Report Number1644487-2002-00250
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/02/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/02/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/31/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300 NCP BIPOLAR LEAD.
 
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