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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 10/01/2013
Event Type  Injury  
Event Description

On (b)(6) 2013 it was reported that the patient has some episodes of a slow heart rate in the 50¿s ever since the vns was turned on a couple of weeks ago. The patient had no reported heart issues prior to vns. There was no report of cardiac issues on diagnostics during implant. The patient¿s current settings were noted to be output=0. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 75ma/magnet on time=60sec/magnet pulse width=500usec. The patient was taken to the er but everything was fine so he was not admitted into the hospital. They have not diagnosed the patient to have bradycardia. Since the patient has only had episodes, they have not seen a direct correlation to vns or stimulation. Good faith attempts for further information from the physician have been made but no additional information 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 Key3485598
Report Number1644487-2013-03591
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2015
Device MODEL Number103
Device LOT Number202485
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/04/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2013
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: 11/25/2013 Patient Sequence Number: 1
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