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MAUDE Adverse Event Report

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

Reporter indicated that the patient developed an infection and the ncp system was replaced. The original electrodes were left in place on the nerve. The patient developed cyst-like lumps over the incision sites and the second ncp system was removed. Reporter indicated that the patient has gone through 10 surgeries to resolve the infection. Reporter indicated that in december 2001, the patient developed another lump in the scar on their neck which made the scar open, exposing the coil from the nerve. It was reported that the patient's family member pulled the coil out with their fingernails. An attempt to obtain additional information was made. No response to date.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd.
suite 600
houston TX 77058 2017
Manufacturer Contact
darlene garner, rac
16511 space center blvd.
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key395392
MDR Report Key406405
Event Key384134
Report Number1644487-2002-00334
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 06/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2002
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 Received06/19/2002
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: 07/19/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NCP BIPOLAR LEAD, MODEL AND S/N UNK.
 
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