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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.NCP PULSE GENERATOR

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 09/01/2003
Event Type  Injury   Patient Outcome  Disability,Life Threatening
Event Description

Reporter indicated that vns patient has become psychotic and believes that radio waves from the device are controlling them. The patient had been scratching and digging at the device in their chest. The patient was hospitalized and their device was programmed to off. Anti-psychotic medications were prescribed. It is believed that this may be a case of forced normalization since the patient had become seizure-free very quickly. The patient was discharged after their behavior settled down a bit. The ncp system remains programmed to off. The patient is reportedly still seizure-free and although they are more rational now, they are still demanding that the ncp system be explanted.

 
Manufacturer Narrative

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

 
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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 F)
CYBERONICS, INC.
100 cyberonics blvd.
suite 600
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
suite 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key478707
MDR Report Key489964
Event Key464498
Report Number1644487-2003-00657
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/18/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2003
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 Number7440
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/18/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2002
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: 10/17/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 05/31/04
DATE OF MFG 05/31/2002, STERILIZATION LOT NO. 6181
MEDICATIONS AT TIME OF EVENT INCLUDED: PARACETAMOL
(DOSAGE UNKNOWN)
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