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MAUDE Adverse Event Report

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CYBERONICS, INC. NCP PULSE GENERATOR MODEL 101 LYJ   Back to Search Results
Model Number 101
Event Date 01/10/2006
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative

Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two years of successful vns therapy.

 
Event Description

Reporter indicated that pt suddenly began to experience serious drop attacks unrelated to his epilepsy. The pt had been implanted for approx 29 months when the drop attacks began and had experienced good efficacy with the vns therapy regarding his seizure control. There had been no changes to either programmed parameters or medication regimen for approx one year. The pt was hospitalized, during which time it was discovered that he was experiencing episodes of bradycardia leading to asystole during device stimulation cycles. The pt also experienced several episodes of syncope during this time. No heart condition has been reported that the pt's device was functioning normally, although specific device diagnostic test results were not provided by physician. Stimulation has been discontinued and explant of the ncp system is planned. The episodes of syncope have reportedly resolved since the device was programmed to off; however the pt's seizures have somewhat worsened in the absence of the vns therapy (to approx 1 seizure per wk). Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two yrs of successful vns therapy.

 
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Brand NameNCP PULSE GENERATOR MODEL 101
Type of DeviceLYJ
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 D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd, ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key678497
MDR Report Key689307
Event Key655965
Report Number1644487-2006-00148
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/16/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/30/2004
Device MODEL Number101
Device LOT Number7630
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2003
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: 03/18/2006 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NEUROCYBERNETIC PROSTHESIS (NCP)BIPOLAR LEAD
2,MODEL 300, S/N UNK
3,MEDICATIONS AT TIME OF EVENT INCLUDE
VALPROATE
4,GABAPENTIN
5,ACETAZOLAMIDE
 
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