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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP)NEUROSTIMULATOR

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CYBERONICS, INC. CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP) NEUROSTIMULATOR   Back to Search Results
Model Number 100
Event Date 08/27/1999
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description

Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.

 
Manufacturer Narrative

Further followup concluded that the pt is doing fine. Explanation of h6: eval of the device could not be performed; the device was not returned.

 
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Brand NameCYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP)
Type of DeviceNEUROSTIMULATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number100
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 Marketed07/16/1997
Manufacturer (Section F)
CYBERONICS, INC.
16511 space center blvd #500
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd #500
houston TX 77058
Device Event Key233599
MDR Report Key241087
Event Key226216
Report Number1644487-1999-00010
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/27/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date02/01/2000
Device MODEL Number100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/27/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/1998
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: 09/21/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
300-20-10916 (LEAD).
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