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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 06/27/2010
Event Type  Injury  
Event Description

Information was received that a vns patient was admitted to hospital for bradycardia and syncope. It was reported that the patient has recently had many episodes of syncope. They also noticed the patient had pauses on the cardiac monitoring. These pauses are erratic, lasting about 3 sec and does not coincide with stimulation. They placed the magnet over the generator for 24 hours and during that time, they didn't see anymore cases of heart pauses. No vns setting changes were made prior to the onset of the events. The patient was set at 1. 25/30/250/21/0. 5 so, a 49% duty cycle. The patient was discharged from the hospital on (b) (6), and there were no further incidents of the heart pauses or syncope, and the event was not duplicated again on the cardiac monitoring equipment. The cardiologist recommended having the patient wear a holter monitor for 20 days to monitor cardiac activity, and will re-assess the patient at that time. The device remains programmed on and per the physician he tested the device following the onset of the events, and it is operating within normal limits. The cause of the syncope and the irregular heart pauses is unknown at this time. It was reported that the patient had a myocardial infarction (mi) in (b) (6) 2010, and at that time he was put on a beta blocker medication. It is unknown if stimulation may be a contributory factor to the recent events, but their treating physician should have more information after (b) (6). Good faith attempts to obtain additional details have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1775112
Report Number1644487-2010-01672
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2007
Device MODEL Number102
Device LOT Number13894
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/27/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/26/2010 Patient Sequence Number: 1
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