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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 01/20/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3679922
Report Number1644487-2014-00690
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/14/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number102
Device LOT Number3273
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/14/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2012
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: 03/14/2014 Patient Sequence Number: 1
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