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MAUDE Adverse Event Report

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

Reporter indicated that patient's seizures worsened following vns implant. It was reported that the patient had daily complex partial seizures pre-vns and that after the vns implant, the patient began convulsing much worse than before. Attempts to obtain additional information has 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.
ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
16511 space center blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key387192
MDR Report Key398141
Event Key376231
Report Number1644487-2002-00255
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/08/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2002
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? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2002
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: 06/04/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300 NCP BIPOLAR LEAD, S/N UNKNOWN.
 
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