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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/01/2011
Event Type  Injury  
Event Description

It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2261210
Report Number1644487-2011-02248
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2006
Device MODEL Number102
Device LOT Number011296
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/30/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2004
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: 09/23/2011 Patient Sequence Number: 1
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