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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/03/2015
Event Type  Injury  
Event Description

It was reported that the vns patient went to the er for a cardioversion. Following the procedure, the patient began experiencing bradycardia, pain, and syncope occurring with stimulation on-times which caused the patient to pass out. It was described that the patient¿s heart rate dropped for 30 seconds every five minutes which caused the patient to have pain and pass out. The patient¿s device was subsequently disabled. Diagnostic results showed normal device function. The patient did not have any issues with vns prior to the cardioversion. No further information relevant to the event has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key4554432
Report Number1644487-2015-04000
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number103
Device LOT Number2163
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2008
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: 02/27/2015 Patient Sequence Number: 1
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