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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

It was reported that a pt developed drop attacks in 2009 (approximately 7. 5 years after being implanted which lead to the pt being hospitalized. The pt also had periodic bradycardia. The device was programmed off and the bradycardia and drop attacks resolved. Additional information received from the pt's physician revealed that the pt does not have a history or a family history of cardiac events. The pt presented with syncope which suggested some sort of arrhythmia. The pt's heart rate prior to the event was 70 and decreased to 10 during the event. The blood pressure was 120/80 prior to the event; however, no blood pressure readings were provided after the event. There were no traumatic events, medication changes, or triggers such as smoking, caffeine intake, etc. That preceded the onset of the bradycardia. The pt is currently taking zonegran, lamictal, and topamax. The bradycardia did not occur during device diagnostics nor did it occur following a setting change. An ecg and polysomnography were performed to diagnosed the arrhythmia. The arrhythmia (bradycardia) is believed to be related to device stimulation and is exaggerated by the device. The pt was hospitalized for the length of testing needed to diagnose the arrhythmia. The arrhythmia has not recurred since the device has been programmed off. Good faith attempts to obtain additional information are currently being made.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1602820
MDR Report Key1558273
Event Key1483620
Report Number1644487-2009-02753
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/30/2010
Device MODEL Number102
Device LOT Number2064
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/16/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
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

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