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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 07/15/2013
Event Type  Injury  
Event Description

It was reported the patient stated that one morning when he was sleeping, he was unable to breathe and catch his breath. "it almost felt like a dream, but i know it wasn't a dream, it was very scary. " the patient mentioned that he was unsure if lowering his dose of topamax had anything to do with the event. His doctor lowered his dose of topamax, after he turned up the vns device. The patient also reported feeling a rapid heart beat when the device is activated. He then stated "i don't think i experience that now. " he received the vns therapy in (b)(6) 2013. He started using topamax approx. 1- 1 1/2 year ago. The patient is still receiving topamax and still has the vns device implanted. Attempts are underway for additional information. No other relevant information has been provided.

 
Event Description

Additional information was received stating that the vns patient did not have a history of dyspnea or heart conditions prior to vns implantation and had no risk factors that made the patient more susceptible to these conditions. It was reported that there were medication changes or other factors that caused or contributed to the patient¿s event, but these changes or factors were not specified. The patient had no prior history of cardiac events and no reported family history of cardiac events. It was noted that the patient did not experience any of the following: bradycardia, tachycardia, and asystole.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3408210
Report Number1644487-2013-03187
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number103
Device LOT Number202464
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/26/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2013
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: 10/14/2013 Patient Sequence Number: 1
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