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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 101 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 10/10/2013
Event Type  Injury  
Event Description

On (b)(6), 2013 a vns treating physician reported that a patient suffered bradycardia after swiping the vns magnet. The patient was admitted to the icu ward at the hospital and the physician plans to assess the vns via device diagnostics. It was later stated that the patient had a ¿vt arrest out of hospital after achieving magnet for a focal seizure¿ and that the patient did not have a prior history of cardiac events. It was reported that the arrhythmia event occurred on (b)(6) 2013. The event did not occur following a medication change. The physician noted that the event was not reproduced at diagnostics or higher stimulation setting and that it was unclear if vns or a seizure explains his event. The arrhythmia event has not recurred and the generator is currently programmed on. The patient¿s epileptologist stated that he would not provide any further information.

 
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Brand NamePULSE GEN MODEL 101
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 Key3465822
Report Number1644487-2013-03469
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2003
Device MODEL Number101
Device LOT Number5213
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/16/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2002
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: 11/13/2013 Patient Sequence Number: 1
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