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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101   Back to Search Results
Model Number 101
Event Date 05/01/2006
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative

Results - (b) (4) system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Conclusions - treating physician indicates that the reported events appear to be related to device stimulation; however, the physician does not know why the pt began to experience these events after more than six years of successful vns therapy.

 
Event Description

Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section F)
CYBERONICS, INC.
houston TX
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 Key1665744
MDR Report Key1629932
Event Key1550276
Report Number1644487-2006-00276
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2001
Device MODEL Number101
Device LOT Number38588C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/03/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2000
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: 03/12/2010 Patient Sequence Number: 1
#TreatmentTreatment Date
BIPOL LEAD: MODEL 300-20, (B) (4)
IMPLANTED:
DEPAKOTE 2500MG Q DAY
CLONAZEPAM 1MG TID
LAMICTAL 50MG BID
INDERAL 120MG Q AM
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